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 Changsha Anxiang Medical Technology Co., Ltd., Bio-Medical Research, Ltd. and BTL Industries, Inc..
FDA 510(k) Cleared Stimulator, Muscle, Powered, For Muscle Conditioning Devices (Product Code NGX)
About Product Code NGX - Regulatory Context
510(k) Submission Activity
162 total 510(k) submissions under product code NGX since 2001, with 162 receiving FDA clearance (average review time: 206 days).
Submission volume has remained relatively stable over the observed period, with 24 submissions in the last 24 months.
FDA Review Time
Recent submissions under NGX have taken an average of 152 days to reach a decision - down from 216 days historically, suggesting improved FDA processing for this classification.
NGX devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →