MYOTRACE 10 BIOFEEDBACK DEVICE

MYOTRACE 10 BIOFEEDBACK DEVICE is an FDA 510(k)-cleared medical device (K895633) manufactured by Noraxon USA, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 12, 1990. Regulation: 8.