Frozen Shoulder Information

What is Frozen Shoulder?

Frozen Shoulder Sneaks Up on You!

Frozen shoulder is more of a condition than an injury. It sneaks up on you over time. Generally speaking, it is how we describe a loss of range of motion in your shoulder and associated pain. Typically, people notice that their shoulder is getting stiff and they can't move with the same range as before. It can start with pain or the pain can come after a period of time, but in the end, the stiffness and pain really reduce how you can move your shoulder.

There are a lot of different types of shoulder issues. You will feel Frozen Shoulder in the area where your arm attaches to your body. If you feel it on the outside of your arm, the issue is more likely going to be discussed as a deltoid or rotator cuff or tendon injury.

A Few Key Terms You May Hear

There are some terms for parts of your shoulder you will hear and we'll discuss these parts in detail a little further on. The technical term used is usually 'Adhesive Capsulitis' - that's just the term some medical people might use. Medical people might also talk about your 'Glenohumeral Joint' which is the area of the body that is affected by the condition - that's what you feel hurting. The Glenohumeral Joint is also sometimes referred to as the 'Shoulder Joint or as the 'shoulder capsule' or 'synovial capsule'. There are a lot of names being used, but generally, to you, it is all the same part of your body. You also might hear reference to a 'coracohumeral ligament' which is a major ligament which holds your arm bone (humerus) to your torso (scapula) at the top of your shoulder.

How that part of your shoulder works

Joints are special parts of the body - they are the spot where two bones meet but they're not supposed to be 'stuck' together because they enable movement. There are very tight ropes or cables called ligaments that connect the end of one bone to the other. Through your regular activity, the bones of a joint can get both pulled and pushed. When your joint gets pulled, the ligaments hold the ends of the bones close together. There are several ligaments in each joint so that no matter which direction the joint gets pulled, there is a ligament to hold it in place in that direction. As rope like structures, Ligaments can't help when the joints are pushed together, they only help when bones get pulled apart.

When a joint gets pushed together, your body needs to make sure the ends of the bones don't grind on each other. You've heard the term 'bone-on-bone' and know it's not a good thing. One major protector is a tissue called 'cartilage'. Cartilage is a very tough and slippery tissue. Your body grows 'cartilage' on the ends of bones to act as a wear-pads, and bump-pads, and slide-pads, so that instead of two bones hitting each other, two bumpers hit instead!

Some joints like your shoulders, knees, ankles, hips, and elbows get pushed harder than others. Your fingers and toes don't experience nearly the same stress. In the joints that need to withstand a lot of abuse, cartilage alone isn't enough.

The shoulder is one of several 'Synovial Joints' that you have in your body. A synovial joint is one that is completely sealed off from the rest of the body. Your body seals it off with a 'synovial membrane', and that sealed off space is called a 'capsule', a 'synovial capsule'. (This capsule is what is being referred to in the term 'Adhesive Capsulitis.) In your shoulder, the capsule encloses the ends of the bones including the cartilage, and some ligaments and nerves.

In a synovial capsule, the body creates a special fluid called 'synovial fluid'. It doesn't just create a little, it fills the capsule tight, so there's so much fluid that the ends of the bones are actually pushed apart. The synovial capsule is a synovial fluid shock absorber that prevents your bones from touching under pressure. If your shoulder takes a huge bump, the shock absorber takes the most of the pressure and, hopefully, the cartilage will provide the rest of the protection if needed.

The synovial fluid is also an incredible lubricant - it's the oil for all the parts of your joint. It's thick like oil, not thin like water. So, as it's pumping up the capsule to keep the bones from bumping on each other it is also lubricating all the parts inside so they slide smoothly over each other as your joint moves.

All the parts in your synovial capsule are living tissue, but the environment is too harsh for blood, so your vascular system (blood flow) doesn't directly enter that part of your joint. Instead, the blood flow exchanges all the good stuff going in and the waste coming out with the synovial fluid at the membrane. Inside the capsule, your synovial fluid actually does the work of the blood that doesn't go there. Your synovial fluid is critical to the health of your joint and critical for healing.

Frozen Shoulder is a very similar condition to osteo-arthritis. It is largely a synovial joint condition where the body is constantly producing collagen. Collagen is type of tissue that your body produces to hold other tissue together. When you have a soft tissue injury, your body responds by producing collagen around the injury as a quick fix to stabilize it and pull it together. Normally, over time, your body grows the native tissue back and reabsorbs the collagen and this is the healing typical process. For a full explanation of the healing cycle, see our all about healing page.

Conditions like Osteoarthritis and Adhesive Capsulitis are the result of the body reacting aggressively in the production of collagen in a joint. As a result, the collagen builds up as fibrosis or scar tissue over the surface of other tissue in the joint, in particular the walls of the synovial cavity or joint capsule. The build up of this tough, tight tissue pulls tissue together that otherwise would have more range of motion. It 'adheres' tissue together which gives us the other half of the term 'adhesive capsulitis'

What Causes Frozen Shoulder

So many websites say, 'the cause of adhesive capsulitis isn't fully understood' which really means the people copying the same stuff over and over don't appreciate what is happening. Adhesive Capsulitis is very well studied. Frozen shoulder happens for a reason. Frozen Shoulder happens because something in your Shoulder Joint - some tissue in your synovial capsule - triggered a healing cycle. It may have been cartilage. It may have been ligament. It may have been the capsule itself. The issue is that your body started a healing response and it's taking it way too far!

With a normal injury, your body produces the collagen to immobilize just the injured tissue. Once the injured spot is immobilized, it goes though the healing process and then eventually reabsorbs the collagen. In the case of ligaments and tendons, people don't realize it, but that process might take up to 2 years. You don't notice because the healing is localized to a tiny piece of tissue and, once it is stabilized, the pain goes away and you don't realize you're still healing for so long.

Adhesive Capsulitis is an unusual response to what your body thinks is a long-term, unhealed injury. Your body thinks it is dealing with an underlying condition - that you have had damage in your shoulder capsule for an extended period of time that hasn't healed. In response to what it thinks is an injury, your body produces more and more synovial fluid. It's trying to pump up the shock absorber, and lubricate the parts to protect the joint, while it provides more synovial fluid to do the work of blood. At the same time, your body is producing collagen. Collagen is tissue that your body produces to pull any damaged tissue, and the capsule itself, tight together.

If the perceived injury has persisted for a long time, your body has been responding that way for a long time. And what happens when you over pump up the shock absorber? You loose range of motion. And those ligaments inside, that are supposed to stop your bones from pulling apart, are strained under the extra pressure too. Your ligaments are already getting pulled tighter by the excess collagen. If your ligaments are pulled extra tight you lose range of motion. When your synovial cavity is pumped beyond full, and the ligaments are stretched to the max, you feel pain and lose range of motion. After a long enough time, the large amount of collagen produced pulls so hard on all the tissue inside the joint, and including the capsule membrane itself, that the entire shoulder joint starts to shrink! That's Frozen Shoulder.

With Frozen Shoulder, your body has gone too far and decided it needs to immobilize the whole joint. And from start to finish, that can take 2 or 3 years. The 'not fully understood' part is just why your body decides it needs to 'heal' your whole joint which, likely, really isn't injured anymore.

Adhesive Capsulitis, left untreated will eventually go away... in a few years. Your body will go through the whole process of immobilization of the injury (even though there isn't a significant injury) to protect it. Then, once it senses that the joint is 'fully protected' it will eventually reabsorb all that immobilizing tissue. There's no known way to turn off the 'healing response' before your body feels it has completed the healing process. So, the only option is to beat it at its own game and help your body with the healing process.

Frozen Shoulder goes away when your body completes the healing cycle. So it's in your best interest to help it feel healed as quickly as possible.

Is There an Underlying Injury Causing the Problem?

Is there really no underlying injury? What may be an underlying injury that your body is responding to? You've probably already read an endless supply of online information repeating the same thing, 'there is no injury but your body is going through a healing cycle anyway'. Of course, they do point out that Adhesive Capsulitis is often caused by surgery, or trauma or some kind of injury and they refer to that as 'Primary Adhesive Capsulitis'. So, Frozen Shoulder can definitely be caused by a prior injury or medical procedure - any damage to the shoulder can trigger it.

When you can't identify an initial cause, it is called 'Secondary Adhesive Capsulitis'. But just because you don't know an initial cause, that doesn't mean there wasn't one! It's possible that something you did or perhaps are still doing resulted in a mild but persistent injury and it just isn't significant enough to be detected on an MRI or other test.

Many people suffer with Frozen Shoulder for years or even indefinitely. And, some people suffer less. You want to be one who suffers less.

What are the factors that cause it to end? As soon as the body perceives the shoulder injury is stabilized (your body doesn't care about test results or a therapist's opinion), the relentless process of excess collagen production ends. Eventually, it puts an end to the perceived damage by immobilizing your joint enough that you can't do much with it at all. At that point the natural reabsorption of the excess collagen begins. That process is slow, though. If the collagen built up for years, it can take years to clear away. It can and it will, largely recover though.

But, maybe there is something in your life that is contributing to the problem? It's worth looking at how you are active, how you sleep, and even what you do when you are idle, to search for factors that may aggravate your condition. You can't fight the process, so you might as well join the battle your body is waging and do everything you can to promote your shoulder health. It's when your body perceives your shoulder to be better, not when a therapist thinks so, or a test says it's good, that the cycle begins to end. Work with your body. Be protective of your shoulder. Look at what factors in your life may aggravate it. Be proactive with therapy that helps your body's natural healing process. Fighting it is only going to make it persist.

What are Potential Aggravating Factors?

Most people with frozen shoulder don't realize their shoulder may actually be injured. This is very common.

As mentioned, bones are separated where they would 'touch' by cartilage that grows over the potential contact areas of the bones. Sometimes that cartilage get's a bit of a tear in it. Sometimes it just gets a bit frayed on the outsides. When the tear is significant you feel it in your shoulder long before frozen shoulder develops. When the cartilage damage is minor though, you may not feel it. Your body produces more synovial fluid to help do all those good things for your cartilage that we discuss above. If the damage heals you never know there was a problem. But if your cartilage doesn't heal (typically because of small repetitive reinjury), your healing response can persist and potentially lead to adhesive capsulitis.

Another potential cause is Osteoarthritis. People often don't realize there are two kinds of Arthritis: Osteoarthritis and rheumatoid arthritis. Rheumatoid arthritis is the bad one because it's a disease-like condition and it is a problem that doesn't go away. But most arthritis is actually osteoarthritis which is a problem coming from overuse - overactivity in a joint. Osteoarthritis can go away if you let up on the activity and let the joint heal. Often, active people develop osteoarthritis in their joints that they don't even realize is there. And the body's response to osteoarthritis is, again, to start producing collagen to help the joint heal. That's actually what osteoarthritis is, a buildup of collagen on the capsule surface that aggravates the joint. When it is mild enough that you don't notice it, but it persists for a long time, then that can cause adhesive capsulitis develop. Before it became well known enough to give it it's own name, adhesive capsulitis was actually called 'periarthritis'.

We want to be clear here: Overactivity that causes osteoarthritis and/or frozen shoulder is when you do something excessively strenuous over and over. If the activity is light, you can do it endlessly and never have to worry about developing arthritis. If the activity is light, the protective elements of the shoulder are always in place, and the joint moves freely, without damage. Lifting medium to light weights repeatedly, constantly swinging or lifting your arms - these are all considered light activity. Even a whole lot of light repetitive activity is not a concern for a healthy shoulder. Your shoulder is designed to do that type of activity repeatedly.

If the activity is heavy though, if you are putting a lot of pressure on the joint during the motion, tissue can rub that shouldn't. Bones can push together or ligaments and tendons can get squeezed to the point the synovial fluid gets squeezed out of the way and the cartilage hit each other. If it happens occasionally, that's not a problem. The bursae and cartilage are there for that purpose, to be a bumper and wear pad during times of heavy strain. But there's a limit when it comes to heavy activity.

If you do a heavy load activity over and over and over again so that the parts of your shoulder are constantly bumping and grinding on each other, then it is possible they get worn down over time faster than they can regenerate. When that is the case, a doctor will tell you the joint has developed osteoarthritis.

Osteoarthritis can go away if you let up on the activity and let the joint heal. Often, active people develop osteoarthritis in their joints that they don't even realize is there. And the body's response to osteoarthritis is, again, to start producing synovial fluid and collagen to help the joint heal. When it is mild enough that you don't notice it, but if it persists for a long time, then that can cause Frozen Shoulder to develop.

Again, it's worth noting that if you are doing mild repetitive activity, you are not likely to sustain any injury no matter how much you do it. If the cartilage on the bones is not being pushed hard enough to bump and rub a lot, then your joint can do that activity forever. If the tendons and ligaments are not being squeezed excessively during repetitive motion then you will be fine. So don't get confused by the terms 'overuse injury' and 'repetitive strain injury'. That sort of injury only occurs if the excessive activity is also excessively strenuous on the joint.

Frozen shoulder is less common in people's dominant arm. That goes to show that regular activity is actually good for your shoulder health. If you are doing exercise and activity as part of your personal therapy for Frozen Shoulder, note that you don't need to add any resistance to the movement. Just the movement alone causes the synovial fluid to move around through your shoulder joint. Remember that the synovial fluid takes the role of blood there so its circulation is important. But just the motion alone is enough. Adding resistance does nothing to supplement circulation and any added stress could aggravate the condition without you realizing it.

Isometric Strain Injury

Your shoulder is designed to be in constant motion. That motion contributes to synovial circulation and prevents the parts of your joints from getting squeezed for too long. Your blood has your heart to pump it through your body, but synovial fluid only moves through your joints as a result of motion. You don't need to be excessive though, and the motion does not need to be under heavy weight. If you have any pain at all when you are moving, then you are doing something you should not be doing. Heed the pain. Move, but heed the pain.

People don't realize, you can actually hurt your shoulder by 'doing nothing'. Constant pressure on a body part when it is not moving can lead to injuries called Isometric Strain Injury. If you are inactive for an extended period of time, and your body is being held in a position where part of it is being squeezed to much and too long, you may be hurting yourself.

You have synovial fluid and bursas buffer between the parts in your body to protect them most of the time. When you move, the synovial fluid is squeezed from between the parts into areas between the bones called synovial capsules. The synovial fluid moves back when the squeeze is released, over and over again. It's designed to work that way. That gentle flow in and out of the bursa to other parts of your body acts as circulation for the synovial fluid to do the work of the blood that isn't there.

Isometric Strain may be hurting your body when you aren't moving at all. This kind of injury happens when you keep your body locked in a certain position for a long period of time. It may be locked straight, or bent, or maybe with a twist. But, if you keep your body pressed into any one position for an extended period of time, that tissue being squeezed can get damaged. Remember the synovial fluid shock absorber? Well, if you keep enough pressure in one place for long enough, the synovial fluid gets pushed out of place until there's nothing between the different tissues. Then, if you move suddenly, maybe not even with a lot of effort, damage is much more likely.

Isometric Strain happens more often than you realize. It's what happens to people who stand in one place for a long time with one or both knees 'locked'. Or think about crossing your legs for a long time when sitting - that torque on your body is severe. Some people cross their ankles when they sleep. Doing so causes the body of the top leg to hyper-extend for hours possibly, constantly pressing on one part of the knee joint.

Shoulders, elbows and wrists often experience isometric strain when we sleep. Do you lie with your arm bent tight and under your head or body as you sleep? Maybe you sit for hours each day in front of your computer with wight leaning on one arm with constant strain on your shoulder with limited or not motion at all. Lying on your side propped up on one elbow as your read or watch TV can put unusual compressive strain on your shoulder joint.

There are things that we do, that maybe you haven't thought about that cause isometric strain in different parts of your body. If you are unsure what caused your situation to start and persist, think about this possibility as well. If this is the culprit then you may need to correct that habit, or you risk causing the injury over and over again. You will need to stop it for some time to at least let your body heal. And when your body heals, then the frozen shoulder goes away. When frozen shoulder gets bad enough, all sorts of regular habits get affected. You're experiencing that already. One of them may actually be part of the underlying issue.

This goes for your tendons and ligaments, bones, cartilage and nerves and the other tissue in your shoulders. If they get squeezed under even modest pressure for a very long time, they can get damaged.

With Isometric Strain, you usually don't notice it when you're actually doing the damage. This makes it hard to figure out, because you end up feeling the pain during other times of activity.

It is quite possible that the activity you are doing when you feel the pain isn't the root cause of the problem. But the pain is an indication that your situation is bad enough that the painful activity may start to make your condition worse. By this point, all sorts of activity may start to make your situation worse. The good news is, that if you correct the underlying cause and treat the condition so it heals, you may be able to resume your favorite activity and never have to worry about frozen shoulder again.

There are other much less common inner body injuries that can result in frozen shoulder. Suffice it to say that if some part of a joint has an injury that you don't know about, and your body is trying to resolve it for a long time, frozen shoulder can result.

Diagnosing Frozen Shoulder - It's Valuable to get Tests

So often people go to their GP complaining about pain and swelling in the shoulder and the doctor says, "it's adhesive capsulitis". It's very common and the symptoms are consistent so they often default to that. When they do diagnostics and don't see any other issue, that is what the diagnosis comes back as Frozen Shoulder. Your Frozen Shoulder may be the result of an underlying injury that goes for an extended time without healing - it's a result of an underlying injury. Yes, the adhesive capsulitis is the cause of your pain, so that's often all the doctor addresses. When they call it frozen shoulder it's because they haven't been able to determine another potential cause of the pain.

As discussed, there are many shoulder issues that can show up as pain and swelling. There could be ligament damage or a torn tendon, or perhaps tendonitis. There could be bone spurs. You might have rheumatoid arthritis or be feeling osteoarthritis without frozen shoulder being part of it. There could be infection. It may be something more serious. Typically, your doctor will do their best to test for and exclude those other potential injuries.

How Long Does Frozen Shoulder Last?

Some people get to this point and realize what may be the root cause. Perhaps it was an increase in activity level or a new activity. Perhaps it was that you have always maintained a fairly high activity level, but as you age, maybe your body can't keep up as well. In many cases, you did something once that caused you to have an injury in the moment, and it didn't have a chance to heal, and the injury has persisted ever since. That's the best scenario, because if that's the case, if you can allow your body to heal and get past that injury, you are likely to be able to return to the same activity level as before and never have the problem again. No matter what the cause, though, your body is responding like there is an underlying injury and you need to let it heal. If your body feels you have healed your injury, regardless of the reason it started in the first place, your frozen shoulder will go away and you will likely be able to resume normal life. That is, if this whole ordeal is dealt with properly...

What Can You Do About Frozen Shoulder?

When you get a diagnosis of 'frozen shoulder', it is common that the condition is the second thing wrong with you.

A lot of the time your doctor won't offer you any treatment and will just tell you to go home, rest and do light exercise. That's because if you rest your shoulder enough, the underlying issue will go away and then so will the frozen shoulder. There's no medicine to cure frozen, so there's nothing more the doctor can do. Regardless of any underlying issue, rest is what is really required. As long as your body thinks there's something to heal, the problem will persist.

What Not to do when you have Frozen Shoulder

The internet is full of bad advice about treating your shoulder. Here's a short list though: It's not from light repetitive activity. Stretching it doesn't solve the underlying problem. Pain killers probably make it worse. Driving through the pain will just make it worse.

What You Should do when you have Frozen Shoulder

For a little while - not forever - it is really helpful to give your shoulder a rest. Even if the diagnostics show no injury, treat it like there is an injury, because that is what your body believes to be the case. In many cases, resting your shoulder for a few weeks will give it time to heal to a point that your body feels it is ahead of the healing / reinjury cycle. It's important to realize that once the pain and swelling go away, your underlying condition may not be completely gone, so take it easy and go back to regular life gradually. If you want to be more proactive about healing the problem, you can click here to visit the Recommended Treatments page.

Rest & Use Conservative Treatments

If you want your Frozen Shoulder to go away as quickly as possible, you need to rest the affected shoulder. Avoid any physical activities that could cause further injury to your shoulder. If your condition developed from a known injury, do your best to avoid the activity that caused thie original injury. Consider using a sling to keep the strain off your injured shoulder and avoid re-injury. A sling doesn't mean don't move though, that's just to prevent you from doing strenuous activity or perhaps change a bad habit (remember isometric strain). You also want to do regular motion to keep the synovial fluid in the joint circulating. Not stretching, just motion.

You can do regular ColdCure^® treatments to control the pain and swelling. The compression during each treatment helps soothe the aggravated tissue in the joint.

You can also focus on healing amy and all tissue in the affected shoulder with regular BFST^® treatments. Your body wants to heal, so BFST will help it do that to the best of its ability. This combination will work to finally get rid of your Frozen Shoulder.

Around the 4-6 week mark you can start doing some light stretching and strengthening exercises. This is to help circulation further and to start rebuilding muscle that may have atrophied during your resting period. Slowly work your way back to your regular level of activity. Remember, Frozen Shoulder is a slow process, it may take a few months to get past it completely, but that's much better than ignoring it and suffering for a few years. Continue doing BFST^® treatments long after the pain disappears to maintain the healing you've done. Do a ColdCure^® treatment if you experience any flare-ups of pain and swelling and after any significant activity.

Surgery Should Be a Last Resort

You don't have to undergo surgery in order to get rid of your issue. You can get rid of your frozen shoulder and the underlying injury with conservative treatments. For many people, another shoulder surgery is what caused their frozen shoulder to start in the first place. However, it's possible that your underlying shoulder condition or injury requires surgery. These are very rare cases.

Avoid surgery at all costs. Before any surgery, always get a second opinion. Surgeons are always quite confident, because surgery is what they do. That doesn't mean that's the right choice for you. You want to do everything you can to let your shoulder heal on its own.

If surgery is your only option, make sure your post-surgery recovery goes as smoothly as possible by using BFST and ColdCure. Use a ColdCure^® Wrap to reduce the inflammation and relieve the pain for the first few days following surgery. Once the inflammation has gone down, promote blood flow to the injured area using a BFST^® Wrap. This will improve your circulation and help you heal faster.

Dealing With Pain

Painkillers are BAD, Not Good

Painkillers mask the pain, causing you to continue to stress and injure your shoulder. This will only make your condition worse. It is understandable that people need relief from the pain, so if you have to take painkillers, restrict them to times when you are at rest. You can use painkillers to help you sleep. If you think Isometric Strain may be happening when you sleep, then painkillers are not a good idea then either. Using them when you are active is a recipe for permanent damage. Your choice of pain killers is important. You can give us a call to discuss which ones are best.

The ColdCure^® Top Shoulder Wrap is designed to relieve the pain associated with adhesive capsulitis. This safe and effective pain reliever is also great at bringing down swelling and inflammation. The ColdCure^® Wrap is incredibly soothing and provides support and protection for your shoulder. The painkilling element is incredibly powerful and it works instantly - there's no 20 minute wait like with pills.

Frozen Shoulder can be extremely painful and debilitating. Painkillers such as ASA or acetaminophen are often used to treat the pain but these drugs do nothing to treat the actual condition. In fact, painkillers are known blood thinners and make the bleeding worse for fresh tissue injuries. Cortisone injections are used in extreme cases but these too are intended to only address the pain. They do not promote healing of the injury itself and they put you at a very high risk of further injury.

Blood Flow is Essential for Healing

You don't have to wait for endless months in pain. You can heal much more quickly with the right treatment. For frozen shoulder, blood flow is the most critical element in rapid recovery. Blood flow feeds the synovial fluid through the synovial walls and is key to keeping the shoulder capsule clean and nourished. Blood Flow Stimulation Therapy^™ (BFST^®) gives your shoulder the blood flow it needs to heal quickly and completely. Don't fight your body, work with it to heal as quickly as possible.

BFST^® brings extra oxygen and nutrient-rich blood to the injured area - a requirement for the body to heal itself. Unfortunately, an injured shoulder at rest often has restricted blood flow, which extends your healing time and greatly increases the amount of scar tissue that your body has to deal with. With a King Brand^® BFST^® shoulder Wrap, blood flow can be stimulated in the area of injury while you are at rest. With improved blood flow and without strenuous physical activity and the risk of re-injury, you can recover from your frozen at a rapid rate.

King Brand^® Quality

King Brand^® soft tissue rehabilitation medical products are the #1 choice by top Athletic Therapists and Medical Practitioners worldwide. We provide guaranteed results and customer satisfaction. Like all King Brand^® products, there simply isn't a better performing option. All King Brand^® products come with a 100% satisfaction guarantee. Try our products and if you are not completely impressed, you can send them back for a full refund. We know you will love them though, because hundreds of thousands of people already use them and rave about the results.

Click here to see our Customer Testimonials

King Brand^® BFST^® and ColdCure^® Wraps are FDA Registered medical devices. They are intended to prevent, treat and cure soft tissue injuries and chronic conditions. Part of being an FDA Registered company means that our products are made from high quality, biocompatible materials. These devices are manufactured and tested to the highest safety standards in the industry.

Click here for more information on our FDA Registration