BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS

BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS is an FDA 510(k)-cleared medical device (K051875) manufactured by Meditech International, 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 March 12, 2006. Regulation: 8.