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
25–48 of 162
Cleared Apr 24, 2024
Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
K232181
Hebei JT Medical Co., Ltd.
Physical Medicine · 275d
Cleared Apr 10, 2024
Electromagnetic Stimulation Systems
K232409
Shanghai Apolo Medical Technology Co., Ltd.
Physical Medicine · 244d
Cleared Mar 13, 2024
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
K233070
Chongqing Rob Linka Science and Technology Co., Ltd.
Physical Medicine · 169d
Cleared Mar 11, 2024
Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
K231789
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 265d
Cleared Feb 27, 2024
Coresculpt & Magsculpt
K222400
K1Med Co., Ltd.
Physical Medicine · 567d
Cleared Jan 08, 2024
Electronic Muscle Stimulator (Model MP01)
K233035
Shenzhen Hengbosi Industrial Co., Ltd.
Neurology · 105d
Cleared Dec 20, 2023
EMS Neck Massager
K233492
Xiamen Comfier Technology Co., Ltd.
Neurology · 51d
Cleared Dec 19, 2023
DEKA LILY
K233470
El.En S.P.A.
Physical Medicine · 55d
Cleared Sep 06, 2023
HI-EMT MAGSHAPE
K230024
Beijing Sano Laser S&T Development Co.,Ltd
Physical Medicine · 245d
Cleared Aug 22, 2023
Nova HD+
K220938
Aura Wellness, LLC
Physical Medicine · 509d
Cleared Jul 07, 2023
Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
K231318
Beijing Adss Development Co., Ltd.
Physical Medicine · 60d
Cleared Jun 16, 2023
Fitness Belt (Model: KLT-07)
K231136
Shenzhen Kelutongda Industrial Co., Ltd.
Physical Medicine · 56d
Cleared Jun 09, 2023
Bemer Therapy System Evo
K231368
Bemer Int AG
Physical Medicine · 29d
Cleared Jun 06, 2023
Gnesis EMS Plus
K230261
Creative Fitness Developments S.L.
Physical Medicine · 126d
Cleared Mar 09, 2023
Powered Muscle Stimulator (Model name:MagGraver F200)
K222875
Nanjing Vishee Medical Technology Co., Ltd.
Physical Medicine · 168d
Cleared Feb 24, 2023
Visionbody
K222386
Vb Technologies AG
Physical Medicine · 200d
Cleared Feb 23, 2023
Neuro20 Pro System
K223797
Neuro20 Technologies
Physical Medicine · 66d
Cleared Jan 31, 2023
XBody Go USA, XBody Pro USA
K221200
Xbody Hungary Kft.
Physical Medicine · 280d
Cleared Dec 03, 2022
truSculpt flex
K212866
Johari Digital Healthcare Limited
Physical Medicine · 451d
Cleared Oct 14, 2022
CoreLevee
K213748
Lutronic Corporation
Physical Medicine · 318d
Cleared Oct 07, 2022
Miha Bodytec II
K221498
Miha Bodytec GmbH
Physical Medicine · 137d
Cleared Aug 25, 2022
WiEMSpro
K211298
Medical Cables S.L.
Physical Medicine · 484d
Cleared May 26, 2022
I-Motion
K212413
I-Motion Group Global Iberica S.L.
Physical Medicine · 296d
Cleared Apr 01, 2022
CoolTone
K220601
Zimmer Medizinsysteme GmbH
Physical Medicine · 30d