ACUMED CARPAL TUNNEL RELEASE KIT

ACUMED CARPAL TUNNEL RELEASE KIT is an FDA 510(k)-cleared medical device (K933638) manufactured by Acu Med, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 1994. Regulation: 8.