NGX
- Product code
- NGX
- Device name
- Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5850
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 163
FDA classification definition
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.
510(k) clearances, last 3 years (33)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253790 | 2026-08-13 | Beijing Winkonlaser Technology Limited | High Intensity Focused Electromagnetic Stimulation D | |
| K253926 | 2026-04-10 | ShenB Co., Ltd. | Diacore | |
| K253636 | 2026-03-12 | Termosalud S.L. | Zionic Pro Max (EMS) | |
| K253408 | 2026-01-16 | Zimmer Medizinsysteme GmbH | CoolTone | |
| K252154 | 2025-12-09 | Guangzhou Longest Medical Technology C | Portable Electro Stimulation Therapy Device (LGT-232 | |
| K253478 | 2025-11-06 | Motive Health, Inc. | Motive Muscle Stimulator for Lower Back (OT01-1003) | |
| K251594 | 2025-08-28 | Syrma Johari Medtech Limited | truFlex | |
| K251706 | 2025-07-30 | Changsha Anxiang Medical Technology Co | TENS and EMS Unit | — |
| K251378 | 2025-07-14 | Zimmer Medizinsysteme GmbH | CoolTone | |
| K251746 | 2025-07-02 | Sofwave Medical, Ltd. | Pure Impact | |
| K250759 | 2025-06-13 | Changsha Anxiang Medical Technology Co | 3 in 1 TENS UNIT | — |
| K242926 | 2025-05-30 | Xbody Hungary Kft. | XBody Go USA, XBody Pro USA | |
| K250038 | 2025-05-19 | Zhengzhou PZ Laser Slim Technology Co. | Muscle Stimulator Device (PZ-100) | |
| K243165 | 2025-05-15 | Eywa Srl | Limfa Therapy System (Limfa Therapy) | |
| K250146 | 2025-04-18 | Sofwave Medical, Ltd. | SofWave System | |
| K243763 | 2025-03-12 | Changsha Anxiang Medical Technology Co | Wireless TENS & EMS Unit | — |
| K241601 | 2025-02-25 | Cpmt Laser (Canadian Pioneer Medical T | EMS (FlexPulse, MagnaCore, Magnetika) | |
| K243511 | 2025-02-10 | Changsha Anxiang Medical Technology Co | OTC TENS & EMS Unit | — |
| K233770 | 2025-01-16 | Pepper Interactive, Inc. | Pepper EMS Training System | |
| K242787 | 2024-12-18 | Changsha Anxiang Medical Technology Co | Tens & Ems Device (TU1080) | — |
| K232982 | 2024-11-25 | Shandong Huamei Technology Co., Ltd. | EMS Sculpt Machine | FDA |
| K242186 | 2024-09-17 | Ofan Intelligent Technology (Guangzhou | Neo Sculptor (OF-NEO001) | — |
| K241685 | 2024-08-07 | Sofwave Medical, Ltd. | SofWave System | |
| K240347 | 2024-07-21 | Zimmer Medizinsysteme GmbH | PTG-05 | |
| K230711 | 2024-05-16 | Guangzhou Xinbo Electronic Co., Ltd. | Pain Therapy Device(Model: P.T.S-X) | — |
| K232181 | 2024-04-24 | Hebei JT Medical Co., Ltd. | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, | |
| K232409 | 2024-04-10 | Shanghai Apolo Medical Technology Co., | Electromagnetic Stimulation Systems | |
| K233070 | 2024-03-13 | Chongqing Rob Linka Science and Techno | Smart Muscle Training Wearables (Model:SM9027,SM9027 | — |
| K231789 | 2024-03-11 | Guangzhou Xinbo Electronic Co., Ltd. | Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | — |
| K222400 | 2024-02-27 | K1Med Co., Ltd. | Coresculpt & Magsculpt | FDA |
| K233035 | 2024-01-08 | Shenzhen Hengbosi Industrial Co., Ltd. | Electronic Muscle Stimulator (Model MP01) | — |
| K233492 | 2023-12-20 | Xiamen Comfier Technology Co., Ltd. | EMS Neck Massager | — |
| K233470 | 2023-12-19 | El.En S.P.A. | DEKA LILY | FDA |
Official FDA classification page: NGX
Classification and pathway per current FDA publications. Data from openFDA (CC0).