Renew NCP-5 External Counterpulsation System

Renew NCP-5 External Counterpulsation System is an FDA 510(k)-cleared medical device (K152115) manufactured by Stage 2 Innovations. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 2015. Regulation: 8.