Fist Assist Devices Model FA-1

Fist Assist Devices Model FA-1 is an FDA 510(k)-cleared medical device (K210281) manufactured by Fist Assist Devices, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 2021. Regulation: 8.