Life Vessel and the FDA
Life Vessel has a 510(k) clearance, it is not FDA APPROVED.
Here is the wording on the difference. In reality these claims are often disingenuous. But regulation over the correct terminology is rarely enforced. Which is a shame and misleading to the consumer.
“Products that pass this clearance process may be referred to as “FDA cleared” or “FDA listed,” but this is not the same as “FDA approved,” which only relates to the prescription drugs and Class 3 devices that have passed PMA. This approval method for Class 2 devices has been the subject of mounting controversy.”
Class 1 can be gauze for Pete’s sake, and Class 2 can be exercise equipment. Not really dangerous stuff.
In truth, the only products that the FDA specifically “approve” are drugs and life-threatening or life-sustaining “Class 3” medical technology (such as defibrillators).
So what is really the benefit to having the Life Vessel cleared or anything for that matter? Nothing in my opinion. You, the consumer, have to figure it all out on your own. Whether it be Life Vessel or the latest and greatest “anything”, you are in charge of your research and due diligence.
Over the years people have asked me if Life Vessel is going for an FDA Approval and I have been told that the Life Vessel will just be cleared and nothing more. Life Vessel didn’t have a clearance for many years and people still came to use Life Vessel. Most people don’t care if Life Vessel is categorized in any way by the FDA, they are looking for the Life Vessel to work for them. People want something that works and don’t care about the labels on Life Vessel.