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Health & Life Co., Ltd.
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HL 188 & HL 189 BODY FAT METER is an FDA 510(k)-cleared medical device (K043414) manufactured by Health & Life Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 2005. Regulation: 8.