THE FM-212A BIOFEEDBACK UNIT

THE FM-212A BIOFEEDBACK UNIT is an FDA 510(k)-cleared medical device (K861950) manufactured by Hosa Technology, 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 21, 1987. Regulation: 8.