Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is an FDA 510(k)-cleared medical device (K180981) manufactured by Stimwave Technologies Incorporated. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 18, 2018. Regulation: 8.