TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM

TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K940160) manufactured by Burke Neutech, 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 May 26, 1994. Regulation: 8.