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