Fist Assist Devices Gets FDA Clearance
June 24, 2021
Fist Assist Devices has received 510(k) marketing clearance from the FDA for its Fist Assist FA-1 device for arm massage and increased arm vein circulation.
The wearable device, which delivers intermittent pneumatic compression for arm massage and increased blood circulation, was previously approved in Canada, Europe and several other markets for increased forearm vein enhancement and after arteriovenous fistula surgery.
The Los Altos Hills, Calif.-based company said the device is now available in the U.S. for the newly cleared indication.