THERMASSAGE ENERGY PRODUCT, MODEL HY5000

THERMASSAGE ENERGY PRODUCT, MODEL HY5000 is an FDA 510(k)-cleared medical device (K032449) manufactured by Migun Medical Instrument Co. , 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 21, 2003. Regulation: 8.