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 Bio-Medical Research, Ltd., Zimmer Medizinsysteme GmbH and Actegy , Ltd..

163
Total
163
Cleared
207d
Avg days
2001
Since
163 devices
73–96 of 163
Cleared Nov 15, 2019
CoolTone
K192940
Zimmer Medizinsysteme GmbH
Physical Medicine · 28d
Cleared Nov 08, 2019
HIVOX Spopad EMS SP-911, SP-921
K192264
Hivox Biotek, Inc.
Physical Medicine · 79d
Cleared Oct 11, 2019
NXPRO Neuromuscular Electrical Stimulation Device
K191181
Neux Technologies, Inc.
Physical Medicine · 162d
Cleared Sep 18, 2019
EMS Belt (Model MC0485)
K183103
Dongguan Yingfeng Metal & Plastic Products Co., Ltd.
Physical Medicine · 315d
Cleared Jul 18, 2019
BionicGym Powered Muscle Stimulator
K182794
Medical Currents, Ltd.
Physical Medicine · 290d
Cleared Jul 05, 2019
BTL 799-2L
K190456
BTL Industries, Inc.
Physical Medicine · 130d
Cleared Jul 05, 2019
Revitive Medic Plus, Revitive Advanced 2
K190924
Actegy , Ltd.
Physical Medicine · 87d
Cleared Jun 21, 2019
emFieldPro
K182963
Zimmer Medizinsysteme GmbH
Physical Medicine · 239d
Cleared Jun 07, 2019
Miha Bodytec II
K182519
Miha Bodytec GmbH
Physical Medicine · 267d
Cleared May 14, 2019
FLIX-EMS
K181419
Casgarum Investment, S.L.
Physical Medicine · 348d
Cleared Apr 05, 2019
Xbody Newave USA
K190038
Xbody Hungary Kft.
Physical Medicine · 87d
Cleared Feb 26, 2019
Body System
K182440
A-1 Engineering
Physical Medicine · 172d
Cleared Feb 26, 2019
Tyece OTC EMS System
K183454
Tyece , Ltd.
Neurology · 75d
Cleared Feb 12, 2019
WiEMSpro
K181955
Medical Cables S.L.
Physical Medicine · 204d
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 Oct 17, 2018
Muscle Trainer
K181728
Shenzhen Kentro Medical Electronics Co., Ltd.
Physical Medicine · 110d
Cleared Sep 20, 2018
Katalyst Mark 1 Muscle Stimulation System Model 2
K181199
Katalyst, Inc.
Physical Medicine · 136d
Cleared Jun 14, 2018
BTL 799-2
K180813
BTL Industries, Inc.
Physical Medicine · 77d
Cleared May 09, 2018
Silk'n MODEL H5003 device
K180279
Home Skinovations , Ltd.
Physical Medicine · 98d
Cleared Dec 04, 2017
PowerDot PD-01M
K172876
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 74d
Cleared Nov 20, 2017
Tyece OTC EMS System, Model EM35
K172241
Tyece , Ltd.
Physical Medicine · 117d
Cleared Sep 06, 2017
Katalyst Mark 1 Muscle Stimulation System
K171035
Katalyst, Inc.
Physical Medicine · 153d
Cleared Aug 03, 2017
Everyway OTC EMS, Model EV-805
K162744
Everyway Medical Instrument Co., Ltd.
Physical Medicine · 307d