MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE

MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE is an FDA 510(k)-cleared medical device (K970051) manufactured by Smith and Nephew Donjoy, 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 July 9, 1997. Regulation: 8.