
Ceragem Co., Ltd.
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CERAGEM-C THERMAL ACUPRESSURE MASSAGER is an FDA 510(k)-cleared medical device (K040031) manufactured by Ceragem 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 27, 2004. Regulation: 8.