E-FIT EF-1280 EMS MACHINE

E-FIT EF-1280 EMS MACHINE is an FDA 510(k)-cleared medical device (K133225) manufactured by Fit-Pro Kft , Ltd.. 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 October 23, 2014. Regulation: 8.