CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K911943) manufactured by Burke, 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 July 18, 1991. Regulation: 8.