King Brand's Registration is far more than just filling out a form or applying. Everything we say and do has been thoroughly reviewed by many Agents, many times over many years.
FDA Agents and Engineers have spent weeks reviewing the claims we make about our products. Well in advance of visiting our facilities they thoroughly went through our website making record of all of the medical claims we make. Then, they visited our facilities to investigate that our claims are valid. During their visits and as follow-up to the process, King Brand supplied the FDA with all the science and technology behind our products, and they reviewed this information to make sure it backed up the claims we make. The review of our claims, and technology behind the devices, was a fundamental part of FDA registering King Brand and our products. If the science didn't back up the products, we would not be FDA registered.
FDA agents have visited our manufacturing facilities on numerous occasions to validate that we are manufacturing what we say we are making in a manner that is safe, effective, and reliable for the customer. FDA has watched our manufacturing process, they have pulled random samples in our facilities and had us test them in their presence, they have thoroughly made sure that we are manufacturing medical grade devices in a medical grade manner.
FDA has thoroughly reviewed our business processes to make sure they comply with the requirements of quality and safety and product traceability that is required for these Class II medical devices.
FDA didn't just do the process once, they did it twice, a few years apart. And in addition to FDA, we have also had the same level of weeks long, on-site review and scrutiny applied by Health Canada to make sure we meet Canadian Medical Device standards. We have also had many on site, multi-day, ISO13485 inspections that verify the same range of compliance to be applicable to International Standards. If any company has had their claims and technology fully reviewed it is King Brand. And we have passed each time with flying-colors. We are committed to producing safe, effective products to help you heal.
King Brand® ColdCure® and BFST® products are FDA Registered medical devices. Our products are intended to treat soft tissue injuries and chronic conditions. They are also ideal for post-surgery recovery. ColdCure® and BFST® medical devices are not consumer goods. A medical device must meet much higher standards than a consumer good when it comes to safety, efficacy, biocompatibility, etc. Many people use non-FDA Registered products to treat their injuries and conditions, and it's important to understand that non-FDA Registered products are not medical devices, they're consumer goods. Consumer goods are not manufactured to the FDA standards King Brand® medical devices are manufactured to. Why don't most manufacturers have FDA Registration? Because it's very expensive and very hard to get. It doesn't just require specifying a certain material. The standards extend to every element of the device and the company.
The FDA is responsible for making sure Americans have access to safe and reliable healthcare. This means the products have to do what they claim and a company cannot claim that a medical device does something it doesn't. It is illegal to make false claims. When you see a customer comment, review or testimonial anywhere on our site we have to be able to trace it back to a real customer. Every single comment on our site can be tied back to a real customer with a real problem who truly used our device(s). It is against the law to make false claims with medical devices so you can trust that everything on this site is true. There are no disclaimers. The FDA is looking out for you.
The FDA holds medical device manufacturers accountable, unlike companies that manufacture consumer goods. The FDA has requirements for medical devices that the companies who manufacture and sell them must meet. The FDA is supported by Federal Law, and if an FDA Registered product or company breaks the rules the FDA have set out, the penalties can be severe. The FDA has much more power over FDA Registered companies than non-FDA Registered companies. This is why so many companies explicitly state that their products have not been reviewed by the FDA. These non-registered companies do not want to be held accountable for their products, because they know their products do not comply with FDA rules. While these rules take a lot of hard work to meet, they are very important to King Brand® and to the people who use our products.
Every complaint King Brand® receives regarding our products is documented, followed up on, and taken very seriously. The FDA makes a point of checking up to ensure this is being done. With FDA Registered medical devices, you cannot simply ignore complaints and take no action. Every complaint we receive is addressed. Root causes of complaints are investigated and appropriate corrective actions are taken. Because our products are FDA Registered medical devices, we fix every issue -- no matter how small.
The workers who assemble our medical devices are trained extensively in each task they perform. Their training is tracked and they are regularly audited to ensure the job is being done right. The FDA expects this and checks that this is being done. The workers who build our medical devices care about quality.
Medical devices have very high material safety standards. These standards are generally higher than those for clothing and baby products. All of our ColdCure® and BFST® Wraps are manufactured with 100% biocompatible materials. This means it is completely safe for the products to come into contact with your body tissue. This is especially important post-surgery, because you don't want non-biocompatible materials coming into contact with your healing tissue. These devices are manufactured and tested to the highest safety standards in the industry.
The FDA doesn't just make recommendations, they make rules that are the law. The FDA insists that medical devices do not pose a health hazard and materials must be manufactured and tested to prove they are safe. In order for our ColdCure® and BFST® products to be sold as FDA Registered medical devices, our materials had to pass biocompatibility testing. Our devices also have to be safe, even if they fail. If one part of the device breaks, the device cannot bring you harm. It may stop working, but it will not cause harm under any circumstances. Safety must be designed into every element of the device.
To sell a non-FDA Registered product, you simply need to make it and sell it. These consumer goods haven't been tested to tough safety standards, and this is why they are just consumer goods and not FDA Registered medical devices.
When you buy a King Brand® product you are buying safety, quality and efficacy that is guaranteed and backed by law. You can't get this with a product that isn't FDA Registered.
Click here to review our FDA Registration information on the FDA website