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Sport-Elec S.A.
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BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 is an FDA 510(k)-cleared medical device (K081026) manufactured by Sport-Elec S.A.. 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 November 4, 2008. Regulation: 8.