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 Zimmer Medizinsysteme GmbH, Changsha Anxiang Medical Technology Co., Ltd. and Guangzhou Xinbo Electronic Co., Ltd..
162
Total
162
Cleared
206d
Avg days
2001
Since
162 devices
Cleared
Dec 17, 2021
Revitive Medic Coach (Model Number 5575AQ)
Actegy , Ltd.
Physical Medicine
273d
Cleared
Dec 13, 2021
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
Shenzhen Osto Technology Company Limited
Physical Medicine
173d
Cleared
Nov 01, 2021
Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine
46d
Cleared
Oct 21, 2021
Legend Pro DMA
Pollogen, Ltd.
Neurology
597d
Cleared
Aug 25, 2021
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
Fit-Pro , Ltd.
Physical Medicine
387d
Cleared
Jul 15, 2021
Pain Therapy Device
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine
307d
Cleared
Apr 06, 2021
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
Arrive Systems, Inc.
Physical Medicine
330d
Cleared
Mar 11, 2021
miha bodytec II
Miha Bodytec GmbH
Physical Medicine
238d
Cleared
Feb 10, 2021
SLENDERTONE Evolve Abs, Type 735
Bio-Medical Research, Ltd.
Physical Medicine
72d
Cleared
Feb 04, 2021
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
Bemer Int AG
Physical Medicine
13d
Cleared
Jan 15, 2021
Gymform Total ABS
Well Brain International , Ltd.
Physical Medicine
123d
Cleared
Jan 06, 2021
BTL-703-2
Btl
Physical Medicine
323d
Cleared
Dec 31, 2020
NuEra Tight Family, EMS Model
Bios S.R.L.
Physical Medicine
238d
Cleared
Dec 11, 2020
TENS & PMS
Hong Qiangxing (Shenzhen) Electronics Limited
Physical Medicine
204d
Cleared
Nov 27, 2020
Compex Sport Elite 3.0
Djo, LLC
Physical Medicine
162d
Cleared
Oct 08, 2020
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
Guangzhou Longest Science & Technology Co., Ltd.
Neurology
94d
Cleared
Sep 17, 2020
Portable Electro-Stimulation Therapy Device
Guangzhou Longest Science & Technology Co., Ltd.
Physical Medicine
783d
Cleared
Aug 28, 2020
FitRelief TENS&EMS Wireless Device
Heat IN A Click, LLC
Neurology
406d
Cleared
May 28, 2020
firefly T-2
Firstkind Limited
Physical Medicine
30d
Cleared
May 04, 2020
Revitive Medic Plus, Revitive Advanced 2
Actegy , Ltd.
Physical Medicine
207d
Cleared
Mar 29, 2020
Torc Body
Johari Digital Healthcare Limited
Physical Medicine
243d
Cleared
Feb 03, 2020
Katalyst Training System
Katalyst, Inc.
Physical Medicine
297d
Cleared
Jan 22, 2020
FastFit EMS System
Fast Fit, LLC
Physical Medicine
166d
Cleared
Nov 15, 2019
CoolTone
Zimmer Medizinsysteme GmbH
Physical Medicine
28d