VitalStim(R) Plus Electrotherapy System

VitalStim(R) Plus Electrotherapy System is an FDA 510(k)-cleared medical device (K153224) manufactured by Djo, LLC. 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 February 16, 2016. Regulation: 8.