
Jg Medical Products, LLC
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ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 is an FDA 510(k)-cleared medical device (K070021) manufactured by Jg Medical Products, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2007. Regulation: 8.