Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is an FDA 510(k)-cleared medical device (K200457) manufactured by CC Wellness, 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 May 21, 2020. Regulation: 8.