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..
164
Total
164
Cleared
206d
Avg days
2001
Since
164 devices
Cleared
Apr 28, 2014
ARASYS
Ion Genius, Inc.
Physical Medicine
287d
Cleared
Feb 07, 2014
FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
Famidoc Technology Co., Ltd.
Physical Medicine
326d
Cleared
Dec 10, 2013
TG-BODY MI&BODY S-TRAINER
Miga Medical Co., Ltd.
Physical Medicine
490d
Cleared
Aug 15, 2013
GYMFORM ABS-A-ROUND
Well Brain International , Ltd.
Physical Medicine
213d
Cleared
Jul 11, 2013
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B
Well-Life Healthcare Limited
Physical Medicine
283d
Cleared
Jun 21, 2013
ION MAGNUM GENIUS
Ion Genius, Inc.
Physical Medicine
255d
Cleared
Jun 14, 2013
TORC BODY
Johari Digital Healthcare , Ltd.
Physical Medicine
39d
Cleared
May 10, 2013
SM TENS & PMS
Hong Qiangxing (Shenzhen) Electronics Limited
Physical Medicine
333d
Cleared
Dec 21, 2012
AB COMMAND DUAL CHANNEL FITNESS BELT
Leto Enterprises Incorporation
Physical Medicine
135d
Cleared
Jul 11, 2012
GYMFORM DUAL FLEX BELT MODEL WB-162
Well Brain International , Ltd.
Physical Medicine
383d
Cleared
May 23, 2012
CONTOUR TECHNOLOGY MUSCLE STIMULATOR
Contour Technology
Physical Medicine
362d
Cleared
Oct 28, 2011
MINI MASSEUSE
Mj Specialty Retail
Physical Medicine
291d
Cleared
Sep 02, 2011
GEM-TONE BODY TRAINING SYSTEM
Gemore Technology Co, Ltd.
Physical Medicine
333d
Cleared
Aug 25, 2011
GEMORE MUSCLE CONDITIONER
Gemore Technology Co, Ltd.
Physical Medicine
325d
Cleared
Jul 01, 2011
WELL-LIFE OTC EMS SYSTEM
Well-Life Healthcare Limited
Physical Medicine
277d
Cleared
Feb 18, 2011
X2ABS DUAL CHANNEL FITNESS BELT
Leto Enterprises Incorporation
Physical Medicine
189d
Cleared
Aug 10, 2010
ARP POV SPORT
Arp Manufacturing, Inc.
Physical Medicine
225d
Cleared
Aug 02, 2010
SLENDERTONE FLEX MAX, MODEL 517 US
Bio-Medical Research, Ltd.
Physical Medicine
154d
Cleared
May 07, 2010
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M
Sport-Elec
Physical Medicine
268d
Cleared
May 05, 2010
SLENDERTONE SYSTEM ULTRA MODEL E70/X70
Bio-Medical Research, Ltd.
Physical Medicine
90d
Cleared
Feb 05, 2010
SPORT-ELEC BODY CONTROL SYSTEM BS
Sport-Elec
Physical Medicine
205d
Cleared
Jan 27, 2010
BUTTERFLY TONER MODEL GYM070
Global Marketing Partners Dba Gymmax USA
Physical Medicine
90d
Cleared
Nov 13, 2009
SPORT-ELEC BODY CONTROL SYSTEM
Sport-Elec
Physical Medicine
147d
Cleared
Oct 16, 2009
GEM-STONE ABDOMINAL TRAINING SYSTEM
Gemore Technology Co, Ltd.
Physical Medicine
116d