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
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
Jul 01, 2011
WELL-LIFE OTC EMS SYSTEM
Well-Life Healthcare Limited
Physical Medicine
277d
Cleared
Aug 02, 2010
SLENDERTONE FLEX MAX, MODEL 517 US
Bio-Medical Research, Ltd.
Physical Medicine
154d
Cleared
May 05, 2010
SLENDERTONE SYSTEM ULTRA MODEL E70/X70
Bio-Medical Research, Ltd.
Physical Medicine
90d
Cleared
Dec 16, 2008
SYSTEM-ARMS, MODELS 390, X60
Bio-Medical Research, Ltd.
Physical Medicine
50d
Cleared
Dec 19, 2007
OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
Well-Life Healthcare Limited
Physical Medicine
135d
Cleared
Dec 14, 2007
SYSTEM-ARMS, MODEL 390,E60
Bio-Medical Research, Ltd.
Physical Medicine
95d
Cleared
Oct 25, 2007
SYSTEM-MINI, MODELS: 390, E30
Bio-Medical Research, Ltd.
Physical Medicine
70d
Cleared
Nov 16, 2005
SLENDERTONE GYMBODY, MODEL 512-01
Bio-Medical Research, Ltd.
Physical Medicine
26d
Cleared
Jun 25, 2003
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
Bio-Medical Research, Ltd.
Physical Medicine
111d
Cleared
Mar 06, 2003
SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511
Bio-Medical Research, Ltd.
Physical Medicine
191d
Cleared
Sep 27, 2001
SLENDERTONE FLEX, MODEL, 512
Bio-Medical Research, Ltd.
Physical Medicine
237d