Are the cuffs FDA approved?Updated 20 days ago

While The BFR Cuffs are not currently registered through the FDA, we are currently moving through the process of registering our cuffs through the FDA as a medical device. The FDA actually does not comment/evaluate BFR devices used during exercise - in fact there are no "FDA Approved" BFR devices. There are some BFR devices that have their manufacturing company listed on the FDA database - this is a self-registration process and constitutes the lowest form of medical device classification (Class 1). Class 1 devices are deemed to have low potential for harm to the user.  Most of these devices are exempt from pre-market review, including pneumatic tourniquets, which BFR devices are categorized as.