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Tohkai Precision Ind. , Ltd.
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WELLNESS/JOLIVETE is an FDA 510(k)-cleared medical device (K040905) manufactured by Tohkai Precision Ind. , 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 February 22, 2005. Regulation: 8.