Intimate Rose Kegel Exercise System

Intimate Rose Kegel Exercise System is an FDA 510(k)-cleared medical device (K193364) manufactured by Plus EV Holdings Dba Intimate Rose. 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 August 23, 2020. Regulation: 8.