MyoCycle MC-2 (Home / Home + / Pro / Pro +)

MyoCycle MC-2 (Home / Home + / Pro / Pro +) is an FDA 510(k)-cleared medical device (K213925) manufactured by Myolyn, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2022. Regulation: 8.