PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER

PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER is an FDA 510(k)-cleared medical device (K031897) 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 September 22, 2003. Regulation: 8.