Katalyst Mark 1 Muscle Stimulation System Model 2

Katalyst Mark 1 Muscle Stimulation System Model 2 is an FDA 510(k)-cleared medical device (K181199) 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 19, 2018. Regulation: 8.