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 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
49–72 of 162
Cleared Dec 17, 2021
Revitive Medic Coach (Model Number 5575AQ)
K210825
Actegy , Ltd.
Physical Medicine · 273d
Cleared Dec 13, 2021
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
K211942
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)
K212948
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 46d
Cleared Oct 21, 2021
Legend Pro DMA
K200545
Pollogen, Ltd.
Neurology · 597d
Cleared Aug 25, 2021
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
K202148
Fit-Pro , Ltd.
Physical Medicine · 387d
Cleared Jul 15, 2021
Pain Therapy Device
K202638
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 307d
Cleared Apr 06, 2021
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
K201257
Arrive Systems, Inc.
Physical Medicine · 330d
Cleared Mar 11, 2021
miha bodytec II
K201975
Miha Bodytec GmbH
Physical Medicine · 238d
Cleared Feb 10, 2021
SLENDERTONE Evolve Abs, Type 735
K203513
Bio-Medical Research, Ltd.
Physical Medicine · 72d
Cleared Feb 04, 2021
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
K210174
Bemer Int AG
Physical Medicine · 13d
Cleared Jan 15, 2021
Gymform Total ABS
K202653
Well Brain International , Ltd.
Physical Medicine · 123d
Cleared Jan 06, 2021
BTL-703-2
K200382
Btl
Physical Medicine · 323d
Cleared Dec 31, 2020
NuEra Tight Family, EMS Model
K201239
Bios S.R.L.
Physical Medicine · 238d
Cleared Dec 11, 2020
TENS & PMS
K201354
Hong Qiangxing (Shenzhen) Electronics Limited
Physical Medicine · 204d
Cleared Nov 27, 2020
Compex Sport Elite 3.0
K201653
Djo, LLC
Physical Medicine · 162d
Cleared Oct 08, 2020
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
K201845
Guangzhou Longest Science & Technology Co., Ltd.
Neurology · 94d
Cleared Sep 17, 2020
Portable Electro-Stimulation Therapy Device
K182020
Guangzhou Longest Science & Technology Co., Ltd.
Physical Medicine · 783d
Cleared Aug 28, 2020
FitRelief TENS&EMS Wireless Device
K191938
Heat IN A Click, LLC
Neurology · 406d
Cleared May 28, 2020
firefly T-2
K201131
Firstkind Limited
Physical Medicine · 30d
Cleared May 04, 2020
Revitive Medic Plus, Revitive Advanced 2
K192887
Actegy , Ltd.
Physical Medicine · 207d
Cleared Mar 29, 2020
Torc Body
K192039
Johari Digital Healthcare Limited
Physical Medicine · 243d
Cleared Feb 03, 2020
Katalyst Training System
K190966
Katalyst, Inc.
Physical Medicine · 297d
Cleared Jan 22, 2020
FastFit EMS System
K192161
Fast Fit, LLC
Physical Medicine · 166d
Cleared Nov 15, 2019
CoolTone
K192940
Zimmer Medizinsysteme GmbH
Physical Medicine · 28d