
Merits Health Products., Inc.
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MP3HD BIG BOY, POWER WHEELCHAIR is an FDA 510(k)-cleared medical device (K010380) manufactured by Merits Health Products., Inc.. 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 May 8, 2001. Regulation: 8.