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
Jul 09, 2009
H-WAVE SPORT
Electronic Waveform Laboratory, Inc.
Physical Medicine
360d
Cleared
Feb 09, 2009
COMPEX SPORT PLUS
Chattanooga Group
Physical Medicine
109d
Cleared
Dec 16, 2008
SYSTEM-ARMS, MODELS 390, X60
Bio-Medical Research, Ltd.
Physical Medicine
50d
Cleared
Nov 05, 2008
BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
Sport-Elec S.A.
Physical Medicine
209d
Cleared
Mar 12, 2008
SLENDERTONE ENERVIVE, MODEL 561
Bio-Medical Research Corp.
Physical Medicine
268d
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
Jul 26, 2007
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
Sport-Elec S.A.
Physical Medicine
385d
Cleared
Apr 30, 2007
GLOBUS PREMIUM MUSCLE STIMULATOR
Domino S.R.L.
Physical Medicine
322d
Cleared
Mar 23, 2007
SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10
Bio-Medical Research Corp.
Physical Medicine
66d
Cleared
Jan 08, 2007
POWERTONE, MODEL PT-11
Johari Digital Healthcare , Ltd.
Physical Medicine
140d
Cleared
Nov 16, 2005
SLENDERTONE GYMBODY, MODEL 512-01
Bio-Medical Research, Ltd.
Physical Medicine
26d
Cleared
Sep 29, 2004
P4-FITNESS
Valmed Corp.
Physical Medicine
496d
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 13, 2002
AB BELT
The Dezac Group
Physical Medicine
217d
Cleared
Sep 13, 2002
AB BELT PRO
The Dezac Group
Physical Medicine
217d
Cleared
Apr 17, 2002
COMPEX SPORT
Compex S.A.
Physical Medicine
306d
Cleared
Sep 27, 2001
SLENDERTONE FLEX, MODEL, 512
Bio-Medical Research, Ltd.
Physical Medicine
237d