Revive Reusable Bladder Support

Revive Reusable Bladder Support is an FDA 510(k)-cleared medical device (K183468) manufactured by Rinovum Subsidiary 2, LLC. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 24, 2019. Regulation: 8.