Gymform Dual Flex Belt Model Wb-162

K111781 is the FDA 510(k) clearance record for GYMFORM DUAL FLEX BELT MODEL WB-162, a class II device, cleared for Well Brain International , Ltd. on 2012-07-11 under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning). FDA's definition for product code NGX reads: "A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties...". FDA records list 4 510(k) clearances for Well Brain International , Ltd., from 2012-07-11 to 2021-01-15. As of 2026-09-10, FDA records show no recalls naming K111781.