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Imc-Heart Way LLC
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ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R) is an FDA 510(k)-cleared medical device (K063307) manufactured by Imc-Heart Way LLC. 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 26, 2007. Regulation: 8.