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Hwang Sun Enterprise Co., Ltd.
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HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) is an FDA 510(k)-cleared medical device (K050410) 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 July 13, 2005. Regulation: 8.