FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM

FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM is an FDA 510(k)-cleared medical device (K141399) 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 October 9, 2014. Regulation: 8.