medi pneumatic compression system (pcs) – brio (Model 651)

medi pneumatic compression system (pcs) – brio (Model 651) is an FDA 510(k)-cleared medical device (K183631) 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 January 24, 2019. Regulation: 8.