NGX
- 产品代码
- NGX
- 器械名称
- Stimulator, Muscle, Powered, For Muscle Conditioning
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 890.5850
- FDA 专业组
- Physical Medicine
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 163 件
FDA 分类定义
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.
该代码近三年的 510(k)（33 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253790 | 2026-08-13 | Beijing Winkonlaser Technology Limited | High Intensity Focused Electromagnetic Stimulation D 摘要 |
| K253926 | 2026-04-10 | ShenB Co., Ltd. | Diacore 摘要 |
| K253636 | 2026-03-12 | Termosalud S.L. | Zionic Pro Max (EMS) 摘要 |
| K253408 | 2026-01-16 | Zimmer Medizinsysteme GmbH | CoolTone 摘要 |
| K252154 | 2025-12-09 | Guangzhou Longest Medical Technology C | Portable Electro Stimulation Therapy Device (LGT-232 摘要 |
| K253478 | 2025-11-06 | Motive Health, Inc. | Motive Muscle Stimulator for Lower Back (OT01-1003) 摘要 |
| K251594 | 2025-08-28 | Syrma Johari Medtech Limited | truFlex 摘要 |
| K251706 | 2025-07-30 | Changsha Anxiang Medical Technology Co | TENS and EMS Unit |
| K251378 | 2025-07-14 | Zimmer Medizinsysteme GmbH | CoolTone 摘要 |
| K251746 | 2025-07-02 | Sofwave Medical, Ltd. | Pure Impact 摘要 |
| 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 摘要 |
| K250038 | 2025-05-19 | Zhengzhou PZ Laser Slim Technology Co. | Muscle Stimulator Device (PZ-100) 摘要 |
| K243165 | 2025-05-15 | Eywa Srl | Limfa Therapy System (Limfa Therapy) 摘要 |
| K250146 | 2025-04-18 | Sofwave Medical, Ltd. | SofWave System 摘要 |
| 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) 摘要 |
| K243511 | 2025-02-10 | Changsha Anxiang Medical Technology Co | OTC TENS & EMS Unit |
| K233770 | 2025-01-16 | Pepper Interactive, Inc. | Pepper EMS Training System 摘要 |
| 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 摘要 |
| K242186 | 2024-09-17 | Ofan Intelligent Technology (Guangzhou | Neo Sculptor (OF-NEO001) |
| K241685 | 2024-08-07 | Sofwave Medical, Ltd. | SofWave System 摘要 |
| K240347 | 2024-07-21 | Zimmer Medizinsysteme GmbH | PTG-05 摘要 |
| 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, 摘要 |
| K232409 | 2024-04-10 | Shanghai Apolo Medical Technology Co., | Electromagnetic Stimulation Systems 摘要 |
| 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 摘要 |
| 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 摘要 |
FDA 官方分类页： NGX
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。