
Coolsystems, Inc.
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GAME READY CLASSIC SYSTEM, MODEL 550550 is an FDA 510(k)-cleared medical device (K072620) 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 October 30, 2007. Regulation: 8.