CyMedica e-vive™ System; CY-1000

CyMedica e-vive™ System; CY-1000 is an FDA 510(k)-cleared medical device (K163067) manufactured by Cymedica Orthopedics, 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 November 30, 2016. Regulation: 8.