
Coolsystems, Inc.
Free shipping on orders over $99 · 30-day returns
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K071050) manufactured by Coolsystems, 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 June 28, 2007. Regulation: 8.