medi pneumatic compression system (pcs)-genius (Model 652)

medi pneumatic compression system (pcs)-genius (Model 652) is an FDA 510(k)-cleared medical device (K221654) manufactured by Medi USA, LP. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 2022. Regulation: 8.