HES ULTRASONIC THERAPY APPLIANCE

HES ULTRASONIC THERAPY APPLIANCE is an FDA 510(k)-cleared medical device (K040798) manufactured by Hwang Sun Enterprise 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 August 3, 2004. Regulation: 8.