Game Ready GRPro 2.1 System

Game Ready GRPro 2.1 System is an FDA 510(k)-cleared medical device (K192114) manufactured by Cool Systems, Inc. (Dba Game Ready). 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 28, 2019. Regulation: 8.