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Are the cuffs FDA-approved?

The BFR cuffs are not yet FDA-registered, although registration as a medical device is currently in progress.

It's worth noting that the FDA does not typically approve BFR devices for exercise use, so no devices in this category are 'officially' FDA-approved. Some such products are listed in the FDA database, but this is due to a basic self-registration by the manufacturer, not a formal review.

BFR devices are typically classified as low-risk (Class I) devices. Many products in this category, including pneumatic tourniquets, do not require pre-market approval.