FDA Product Code NGX: Stimulator, Muscle, Powered, For Muscle Conditioning
FDA product code NGX covers powered muscle stimulators specifically cleared for muscle conditioning — distinct from therapeutic stimulators used for rehabilitation.
These devices deliver electrical impulses to healthy muscle groups to enhance strength, endurance, or recovery in athletic and wellness applications. They are used in sports medicine, physical conditioning programs, and post-operative muscle maintenance.
NGX devices are Class II medical devices, regulated under 21 CFR 890.5850 and reviewed by the FDA Physical Medicine panel.
Leading manufacturers include Bio-Medical Research, Ltd., BTL Industries, Inc. and Lutronic Corporation.
List of Stimulator, Muscle, Powered, For Muscle Conditioning devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Stimulator, Muscle, Powered, For Muscle Conditioning devices (product code NGX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Physical Medicine FDA review panel. Browse all Physical Medicine devices →