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 Zimmer Medizinsysteme GmbH, Changsha Anxiang Medical Technology Co., Ltd. and Guangzhou Xinbo Electronic Co., Ltd..
162
Total
162
Cleared
206d
Avg days
2001
Since
162 devices
Cleared
Nov 08, 2019
HIVOX Spopad EMS SP-911, SP-921
Hivox Biotek, Inc.
Physical Medicine
79d
Cleared
Oct 11, 2019
NXPRO Neuromuscular Electrical Stimulation Device
Neux Technologies, Inc.
Physical Medicine
162d
Cleared
Sep 18, 2019
EMS Belt (Model MC0485)
Dongguan Yingfeng Metal & Plastic Products Co., Ltd.
Physical Medicine
315d
Cleared
Jul 18, 2019
BionicGym Powered Muscle Stimulator
Medical Currents, Ltd.
Physical Medicine
290d
Cleared
Jul 05, 2019
BTL 799-2L
BTL Industries, Inc.
Physical Medicine
130d
Cleared
Jul 05, 2019
Revitive Medic Plus, Revitive Advanced 2
Actegy , Ltd.
Physical Medicine
87d
Cleared
Jun 21, 2019
emFieldPro
Zimmer Medizinsysteme GmbH
Physical Medicine
239d
Cleared
Jun 07, 2019
Miha Bodytec II
Miha Bodytec GmbH
Physical Medicine
267d
Cleared
May 14, 2019
FLIX-EMS
Casgarum Investment, S.L.
Physical Medicine
348d
Cleared
Apr 05, 2019
Xbody Newave USA
Xbody Hungary Kft.
Physical Medicine
87d
Cleared
Feb 26, 2019
Body System
A-1 Engineering
Physical Medicine
172d
Cleared
Feb 26, 2019
Tyece OTC EMS System
Tyece , Ltd.
Neurology
75d
Cleared
Feb 12, 2019
WiEMSpro
Medical Cables S.L.
Physical Medicine
204d
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
Oct 17, 2018
Muscle Trainer
Shenzhen Kentro Medical Electronics Co., Ltd.
Physical Medicine
110d
Cleared
Sep 20, 2018
Katalyst Mark 1 Muscle Stimulation System Model 2
Katalyst, Inc.
Physical Medicine
136d
Cleared
Jun 14, 2018
BTL 799-2
BTL Industries, Inc.
Physical Medicine
77d
Cleared
May 09, 2018
Silk'n MODEL H5003 device
Home Skinovations , Ltd.
Physical Medicine
98d
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