PACE SAVER LITTLE JUNIOR (MODIFICATION)

PACE SAVER LITTLE JUNIOR (MODIFICATION) is an FDA 510(k)-cleared medical device (K954974) manufactured by Burke Mobility Products. 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 March 18, 1996. Regulation: 8.