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..
162
Total
162
Cleared
206d
Avg days
2001
Since
162 devices
Cleared
Apr 24, 2024
Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
Hebei JT Medical Co., Ltd.
Physical Medicine
275d
Cleared
Apr 10, 2024
Electromagnetic Stimulation Systems
Shanghai Apolo Medical Technology Co., Ltd.
Physical Medicine
244d
Cleared
Mar 13, 2024
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
Chongqing Rob Linka Science and Technology Co., Ltd.
Physical Medicine
169d
Cleared
Mar 11, 2024
Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine
265d
Cleared
Feb 27, 2024
Coresculpt & Magsculpt
K1Med Co., Ltd.
Physical Medicine
567d
Cleared
Jan 08, 2024
Electronic Muscle Stimulator (Model MP01)
Shenzhen Hengbosi Industrial Co., Ltd.
Neurology
105d
Cleared
Dec 19, 2023
DEKA LILY
El.En S.P.A.
Physical Medicine
55d
Cleared
Oct 14, 2022
CoreLevee
Lutronic Corporation
Physical Medicine
318d
Cleared
Feb 10, 2021
SLENDERTONE Evolve Abs, Type 735
Bio-Medical Research, Ltd.
Physical Medicine
72d
Cleared
Jul 05, 2019
BTL 799-2L
BTL Industries, Inc.
Physical Medicine
130d
Cleared
Oct 25, 2018
SLENDERTONE CoreFit Abs 8, Type 734
Bio-Medical Research, Ltd.
Physical Medicine
224d
Cleared
Oct 23, 2018
BTL 799-2T
BTL Industries, Inc.
Physical Medicine
81d
Cleared
Jun 14, 2018
BTL 799-2
BTL Industries, Inc.
Physical Medicine
77d
Cleared
Feb 16, 2017
AM-100
BTL Industries, Inc.
Physical Medicine
98d
Cleared
Nov 01, 2016
SLENDERTONE® Connect Abs, Type 570
Bio-Medical Research, Ltd.
Physical Medicine
106d
Cleared
Nov 06, 2015
Slendertone connect Abs
Bio-Medical Research, Ltd.
Physical Medicine
119d