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 Changsha Anxiang Medical Technology Co., Ltd..

163
Total
163
Cleared
207d
Avg days
2001
Since
163 devices
97–120 of 163
Cleared Jul 10, 2017
XiniWave II Model ECS322P
K171092
International Trade Group, Inc.
Physical Medicine · 89d
Cleared Jun 20, 2017
Compex Sport Elite
K170918
Djo, LLC
Physical Medicine · 83d
Cleared Jun 19, 2017
Compex Wireless USA
K170903
Djo, LLC
Physical Medicine · 83d
Cleared Apr 06, 2017
FlowKeepers
K160323
Dk Electronics, LLC
Physical Medicine · 426d
Cleared Feb 22, 2017
BEMER Classic Set, BEMER Pro-Set
K151834
Bemer Int AG
Physical Medicine · 597d
Cleared Feb 16, 2017
AM-100
K163165
BTL Industries, Inc.
Physical Medicine · 98d
Cleared Dec 01, 2016
AK Body Toning Device
K152420
Ak Beauty Enterprises, LLC
Physical Medicine · 463d
Cleared Nov 01, 2016
SLENDERTONE® Connect Abs, Type 570
K161974
Bio-Medical Research, Ltd.
Physical Medicine · 106d
Cleared Mar 31, 2016
Revitive Medic
K152480
Actegy , Ltd.
Physical Medicine · 213d
Cleared Mar 18, 2016
Slim UP ULTRA
K151722
Aime Medical, Inc.
Physical Medicine · 267d
Cleared Nov 06, 2015
Slendertone connect Abs
K151903
Bio-Medical Research, Ltd.
Physical Medicine · 119d
Cleared Sep 30, 2015
PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
K150078
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 258d
Cleared Jul 27, 2015
EM25 - glute toning device
K143737
Hivox Biotek, Inc.
Physical Medicine · 209d
Cleared Jun 16, 2015
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
K141919
Ad Rem Technology Sarl
Physical Medicine · 336d
Cleared May 11, 2015
GYMFORM ABS & CORE
K142055
Well Brain International , Ltd.
Physical Medicine · 286d
Cleared Apr 28, 2015
Compex Wireless USA
K143551
Djo, LLC
Physical Medicine · 134d
Cleared Mar 23, 2015
Revitive IX (OTC)
K143207
Actegy , Ltd.
Physical Medicine · 136d
Cleared Jan 26, 2015
TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
K143059
Tone-A-Matic International, Inc.
Physical Medicine · 94d
Cleared Jan 16, 2015
HIVOX SPOPAD EMS
K141921
Hivox Biotek, Inc.
Physical Medicine · 184d
Cleared Oct 24, 2014
E-FIT EF-1280 EMS MACHINE
K133225
Fit-Pro Kft , Ltd.
Physical Medicine · 368d
Cleared Aug 05, 2014
FIT BELT
K133108
Hong Qiangxing (Shenzhen) Electronics Limited
Physical Medicine · 309d
Cleared Jun 16, 2014
OTC EMS STIMULATOR
K133965
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 174d
Cleared May 15, 2014
FIREFLY
K134001
Firstkind Limited
Physical Medicine · 139d
Cleared Apr 28, 2014
ARASYS
K132179
Ion Genius, Inc.
Physical Medicine · 287d