NGX · Class II · 21 CFR 890.5850

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
25–48 of 162
Cleared Apr 24, 2024
Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
K232181
Hebei JT Medical Co., Ltd.
Physical Medicine · 275d
Cleared Apr 10, 2024
Electromagnetic Stimulation Systems
K232409
Shanghai Apolo Medical Technology Co., Ltd.
Physical Medicine · 244d
Cleared Mar 13, 2024
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
K233070
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)
K231789
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 265d
Cleared Feb 27, 2024
Coresculpt & Magsculpt
K222400
K1Med Co., Ltd.
Physical Medicine · 567d
Cleared Jan 08, 2024
Electronic Muscle Stimulator (Model MP01)
K233035
Shenzhen Hengbosi Industrial Co., Ltd.
Neurology · 105d
Cleared Dec 19, 2023
DEKA LILY
K233470
El.En S.P.A.
Physical Medicine · 55d
Cleared Oct 14, 2022
CoreLevee
K213748
Lutronic Corporation
Physical Medicine · 318d
Cleared Feb 10, 2021
SLENDERTONE Evolve Abs, Type 735
K203513
Bio-Medical Research, Ltd.
Physical Medicine · 72d
Cleared Jul 05, 2019
BTL 799-2L
K190456
BTL Industries, Inc.
Physical Medicine · 130d
Cleared Oct 25, 2018
SLENDERTONE CoreFit Abs 8, Type 734
K180688
Bio-Medical Research, Ltd.
Physical Medicine · 224d
Cleared Oct 23, 2018
BTL 799-2T
K182106
BTL Industries, Inc.
Physical Medicine · 81d
Cleared Jun 14, 2018
BTL 799-2
K180813
BTL Industries, Inc.
Physical Medicine · 77d
Cleared Feb 16, 2017
AM-100
K163165
BTL Industries, Inc.
Physical Medicine · 98d
Cleared Nov 01, 2016
SLENDERTONE® Connect Abs, Type 570
K161974
Bio-Medical Research, Ltd.
Physical Medicine · 106d
Cleared Nov 06, 2015
Slendertone connect Abs
K151903
Bio-Medical Research, Ltd.
Physical Medicine · 119d