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Impact Applications, Inc.
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ImPACT Computerized Neurocognitive Concussion Management Aid is an FDA 510(k)-cleared medical device (DEN150037) manufactured by Impact Applications, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2016. Regulation: 8.