SLENDERTONE FLEX, MODEL, 512

SLENDERTONE FLEX, MODEL, 512 is an FDA 510(k)-cleared medical device (K010335) manufactured by Bio-Medical Research, Ltd.. 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 26, 2001. Regulation: 8.