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Tanita Corp. of America
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TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) is an FDA 510(k)-cleared medical device (K040778) manufactured by Tanita Corp. of America. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 2004. Regulation: 8.