Katalyst Mark 1 Muscle Stimulation System

Katalyst Mark 1 Muscle Stimulation System is an FDA 510(k)-cleared medical device (K171035) manufactured by Katalyst, Inc.. 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 5, 2017. Regulation: 8.