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..

164
Total
164
Cleared
206d
Avg days
2001
Since
164 devices
145–164 of 164
Cleared Jul 09, 2009
H-WAVE SPORT
K081998
Electronic Waveform Laboratory, Inc.
Physical Medicine · 360d
Cleared Feb 09, 2009
COMPEX SPORT PLUS
K083140
Chattanooga Group
Physical Medicine · 109d
Cleared Dec 16, 2008
SYSTEM-ARMS, MODELS 390, X60
K083164
Bio-Medical Research, Ltd.
Physical Medicine · 50d
Cleared Nov 05, 2008
BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
K081026
Sport-Elec S.A.
Physical Medicine · 209d
Cleared Mar 12, 2008
SLENDERTONE ENERVIVE, MODEL 561
K071666
Bio-Medical Research Corp.
Physical Medicine · 268d
Cleared Dec 19, 2007
OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
K072168
Well-Life Healthcare Limited
Physical Medicine · 135d
Cleared Dec 14, 2007
SYSTEM-ARMS, MODEL 390,E60
K072553
Bio-Medical Research, Ltd.
Physical Medicine · 95d
Cleared Oct 25, 2007
SYSTEM-MINI, MODELS: 390, E30
K072294
Bio-Medical Research, Ltd.
Physical Medicine · 70d
Cleared Jul 26, 2007
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
K061914
Sport-Elec S.A.
Physical Medicine · 385d
Cleared Apr 30, 2007
GLOBUS PREMIUM MUSCLE STIMULATOR
K061632
Domino S.R.L.
Physical Medicine · 322d
Cleared Mar 23, 2007
SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10
K070142
Bio-Medical Research Corp.
Physical Medicine · 66d
Cleared Jan 08, 2007
POWERTONE, MODEL PT-11
K062439
Johari Digital Healthcare , Ltd.
Physical Medicine · 140d
Cleared Nov 16, 2005
SLENDERTONE GYMBODY, MODEL 512-01
K052969
Bio-Medical Research, Ltd.
Physical Medicine · 26d
Cleared Sep 29, 2004
P4-FITNESS
K031611
Valmed Corp.
Physical Medicine · 496d
Cleared Jun 25, 2003
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
K030708
Bio-Medical Research, Ltd.
Physical Medicine · 111d
Cleared Mar 06, 2003
SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511
K022855
Bio-Medical Research, Ltd.
Physical Medicine · 191d
Cleared Sep 13, 2002
AB BELT
K020427
The Dezac Group
Physical Medicine · 217d
Cleared Sep 13, 2002
AB BELT PRO
K020429
The Dezac Group
Physical Medicine · 217d
Cleared Apr 17, 2002
COMPEX SPORT
K011880
Compex S.A.
Physical Medicine · 306d
Cleared Sep 27, 2001
SLENDERTONE FLEX, MODEL, 512
K010335
Bio-Medical Research, Ltd.
Physical Medicine · 237d