ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)

ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) is an FDA 510(k)-cleared medical device (K063203) 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 12, 2007. Regulation: 8.