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 Actegy , Ltd..

163
Total
163
Cleared
207d
Avg days
2001
Since
163 devices
121–144 of 163
Cleared Feb 07, 2014
FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
K130723
Famidoc Technology Co., Ltd.
Physical Medicine · 326d
Cleared Dec 10, 2013
TG-BODY MI&BODY S-TRAINER
K122393
Miga Medical Co., Ltd.
Physical Medicine · 490d
Cleared Aug 15, 2013
GYMFORM ABS-A-ROUND
K130074
Well Brain International , Ltd.
Physical Medicine · 213d
Cleared Jul 11, 2013
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B
K123075
Well-Life Healthcare Limited
Physical Medicine · 283d
Cleared Jun 21, 2013
ION MAGNUM GENIUS
K123158
Ion Genius, Inc.
Physical Medicine · 255d
Cleared Jun 14, 2013
TORC BODY
K131291
Johari Digital Healthcare , Ltd.
Physical Medicine · 39d
Cleared May 10, 2013
SM TENS & PMS
K121719
Hong Qiangxing (Shenzhen) Electronics Limited
Physical Medicine · 333d
Cleared Dec 21, 2012
AB COMMAND DUAL CHANNEL FITNESS BELT
K122414
Leto Enterprises Incorporation
Physical Medicine · 135d
Cleared Jul 11, 2012
GYMFORM DUAL FLEX BELT MODEL WB-162
K111781
Well Brain International , Ltd.
Physical Medicine · 383d
Cleared May 23, 2012
CONTOUR TECHNOLOGY MUSCLE STIMULATOR
K111476
Contour Technology
Physical Medicine · 362d
Cleared Oct 28, 2011
MINI MASSEUSE
K110057
Mj Specialty Retail
Physical Medicine · 291d
Cleared Jul 01, 2011
WELL-LIFE OTC EMS SYSTEM
K102786
Well-Life Healthcare Limited
Physical Medicine · 277d
Cleared Aug 02, 2010
SLENDERTONE FLEX MAX, MODEL 517 US
K100556
Bio-Medical Research, Ltd.
Physical Medicine · 154d
Cleared May 05, 2010
SLENDERTONE SYSTEM ULTRA MODEL E70/X70
K100320
Bio-Medical Research, Ltd.
Physical Medicine · 90d
Cleared Dec 16, 2008
SYSTEM-ARMS, MODELS 390, X60
K083164
Bio-Medical Research, Ltd.
Physical Medicine · 50d
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 Nov 16, 2005
SLENDERTONE GYMBODY, MODEL 512-01
K052969
Bio-Medical Research, Ltd.
Physical Medicine · 26d
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 27, 2001
SLENDERTONE FLEX, MODEL, 512
K010335
Bio-Medical Research, Ltd.
Physical Medicine · 237d