SPORT-ELEC BODY CONTROL SYSTEM

SPORT-ELEC BODY CONTROL SYSTEM is an FDA 510(k)-cleared medical device (K091865) manufactured by Sport-Elec. 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 November 12, 2009. Regulation: 8.