
Warepalmy Enterprise, LLC (Usa)
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C.T.M. MOBILITY SCOOTER MODEL # HS-320 is an FDA 510(k)-cleared medical device (K012791) manufactured by Warepalmy Enterprise, LLC (Usa). 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 October 23, 2001. Regulation: 8.