Are the cuffs FDA approved?Updated 2 months 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.