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Panels › Physical Medicine › Product code NGX · Class 2

Stimulator, Muscle, Powered, For Muscle Conditioning

Regulation 890.5850

6510(k)s in 12 months (163 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
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Top companies in NGX

Company510(k)sRecalls
Bio-Medical Research Corp.150
Zimmer Medizinsysteme GmbH60
Actegy , Ltd.50
Changsha Anxiang Medical Technology Co., Ltd.50
Sport-Elec50
Bemer Int AG31
BTL Industries, Inc.40
Djo, LLC40
Guangzhou Xinbo Electronic Co., Ltd.40
Johari Digital Healthcare , Ltd.40
Decided510(k)Device and applicantCode
Aug 13, 2026K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)
Beijing Winkonlaser Technology Limited, CN
NGX
Apr 10, 2026K253926Diacore
ShenB Co., Ltd., KR
NGX
Mar 12, 2026K253636Zionic Pro Max (EMS)
Termosalud S.L., ES
NGX
Jan 16, 2026K253408CoolTone
Zimmer Medizinsysteme GmbH, DE
NGX
Dec 9, 2025K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
Guangzhou Longest Medical Technology Co., Ltd., CN
NGX
Nov 6, 2025K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)
Motive Health, Inc.
NGX
Aug 28, 2025K251594truFlex
Syrma Johari Medtech Limited, IN
NGX
Jul 30, 2025K251706TENS and EMS Unit
Changsha Anxiang Medical Technology Co., Ltd., CN
NGX
Jul 14, 2025K251378CoolTone
Zimmer Medizinsysteme GmbH, DE
NGX
Jul 2, 2025K251746Pure Impact
Sofwave Medical, Ltd., IL
NGX
Jun 13, 2025K2507593 in 1 TENS UNIT
Changsha Anxiang Medical Technology Co., Ltd., CN
NGX
May 30, 2025K242926XBody Go USA, XBody Pro USA
Xbody Hungary Kft., HU
NGX
May 19, 2025K250038Muscle Stimulator Device (PZ-100)
Zhengzhou PZ Laser Slim Technology Co., Ltd., CN
NGX
May 15, 2025K243165Limfa Therapy System (Limfa Therapy)
Eywa Srl, IT
NGX
Apr 18, 2025K250146SofWave System
Sofwave Medical, Ltd., IL
NGX
Mar 12, 2025K243763Wireless TENS & EMS Unit
Changsha Anxiang Medical Technology Co., Ltd., CN
NGX
Feb 25, 2025K241601EMS (FlexPulse, MagnaCore, Magnetika)
Cpmt Laser (Canadian Pioneer Medical Technology Corporation), CA
NGX
Feb 10, 2025K243511OTC TENS & EMS Unit
Changsha Anxiang Medical Technology Co., Ltd., CN
NGX
Jan 16, 2025K233770Pepper EMS Training System
Pepper Interactive, Inc.
NGX
Dec 18, 2024K242787Tens & Ems Device (TU1080)
Changsha Anxiang Medical Technology Co., Ltd., CN
NGX
Nov 25, 2024K232982EMS Sculpt Machine
Shandong Huamei Technology Co., Ltd., CN
NGX
Sep 17, 2024K242186Neo Sculptor (OF-NEO001)
Ofan Intelligent Technology (Guangzhou) Co. , Ltd., CN
NGX
Aug 7, 2024K241685SofWave System
Sofwave Medical, Ltd., IL
NGX
Jul 21, 2024K240347PTG-05
Zimmer Medizinsysteme GmbH, DE
NGX
May 16, 2024K230711Pain Therapy Device(Model: P.T.S-X)
Guangzhou Xinbo Electronic Co., Ltd., CN
NGX
Apr 24, 2024K232181Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
Hebei JT Medical Co., Ltd., CN
NGX
Apr 10, 2024K232409Electromagnetic Stimulation Systems
Shanghai Apolo Medical Technology Co., Ltd., CN
NGX
Mar 13, 2024K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
Chongqing Rob Linka Science and Technology Co., Ltd., CN
NGX
Mar 11, 2024K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
Guangzhou Xinbo Electronic Co., Ltd., CN
NGX
Feb 27, 2024K222400Coresculpt & Magsculpt
K1Med Co., Ltd., KR
NGX
Jan 8, 2024K233035Electronic Muscle Stimulator (Model MP01)
Shenzhen Hengbosi Industrial Co., Ltd., CN
NGX
Dec 20, 2023K233492EMS Neck Massager
Xiamen Comfier Technology Co., Ltd., CN
NGX
Dec 19, 2023K233470DEKA LILY
El.En S.P.A., IT
NGX
Sep 6, 2023K230024HI-EMT MAGSHAPE
Beijing Sano Laser S&T Development Co.,Ltd, CN
NGX
Aug 22, 2023K220938Nova HD+
Aura Wellness, LLC
NGX
Jul 7, 2023K231318Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
Beijing Adss Development Co., Ltd., CN
NGX
Jun 16, 2023K231136Fitness Belt (Model: KLT-07)
Shenzhen Kelutongda Industrial Co., Ltd., CN
NGX
Jun 9, 2023K231368Bemer Therapy System Evo
Bemer Int AG, LI
NGX
Jun 6, 2023K230261Gnesis EMS Plus
Creative Fitness Developments S.L., ES
NGX
Mar 9, 2023K222875Powered Muscle Stimulator (Model name:MagGraver F200)
Nanjing Vishee Medical Technology Co., Ltd., CN
NGX
Feb 24, 2023K222386Visionbody
Vb Technologies AG, CH
NGX
Feb 23, 2023K223797Neuro20 Pro System
Neuro20 Technologies
NGX
Jan 31, 2023K221200XBody Go USA, XBody Pro USA
Xbody Hungary Kft., HU
NGX
Dec 3, 2022K212866truSculpt flex
Johari Digital Healthcare Limited, IN
NGX
Oct 14, 2022K213748CoreLevee
Lutronic Corporation, KR
NGX
Oct 7, 2022K221498Miha Bodytec II
Miha Bodytec GmbH, DE
NGX
Aug 25, 2022K211298WiEMSpro
Medical Cables S.L., ES
NGX
May 26, 2022K212413I-Motion
I-Motion Group Global Iberica S.L., ES
NGX
Apr 1, 2022K220601CoolTone
Zimmer Medizinsysteme GmbH, DE
NGX
Dec 17, 2021K210825Revitive Medic Coach (Model Number 5575AQ)
Actegy , Ltd., GB
NGX

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