
Cool Systems, Inc. (Dba Game Ready)
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Med4 Elite is an FDA 510(k)-cleared medical device (K171685) 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 September 28, 2017. Regulation: 8.

Synthes (Usa)
SKU K100676
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SKU VM-1270020

Cardinal Health
SKU VM-1270026
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SKU VM-1270057