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