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NGX

Stimulator, Muscle, Powered, For Muscle Conditioning

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)
33 件
其中 Summary 已存档
19 份,可直接下载
FDA 历史累计 510(k)
163 件(全部年份;本站只收录近三年的明细)

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.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(33 件)

数据窗口为最近三年。最新一件:2026-08-13。

510(k) 号批准日期申请人器械名称摘要
K2537902026-08-13Beijing Winkonlaser Technology LimitedHigh Intensity Focused Electromagnetic Stimulation D…PDF
K2539262026-04-10ShenB Co., Ltd.DiacorePDF
K2536362026-03-12Termosalud S.L.Zionic Pro Max (EMS)PDF
K2534082026-01-16Zimmer Medizinsysteme GmbHCoolTonePDF
K2521542025-12-09Guangzhou Longest Medical Technology C…Portable Electro Stimulation Therapy Device (LGT-232…PDF
K2534782025-11-06Motive Health, Inc.Motive™ Muscle Stimulator for Lower Back (OT01-1003)PDF
K2515942025-08-28Syrma Johari Medtech LimitedtruFlexPDF
K2517062025-07-30Changsha Anxiang Medical Technology Co…TENS and EMS Unit—
K2513782025-07-14Zimmer Medizinsysteme GmbHCoolTonePDF
K2517462025-07-02Sofwave Medical, Ltd.Pure ImpactPDF
K2507592025-06-13Changsha Anxiang Medical Technology Co…3 in 1 TENS UNIT—
K2429262025-05-30Xbody Hungary Kft.XBody Go USA, XBody Pro USAPDF
K2500382025-05-19Zhengzhou PZ Laser Slim Technology Co.…Muscle Stimulator Device (PZ-100)PDF
K2431652025-05-15Eywa SrlLimfa Therapy System (Limfa Therapy)PDF
K2501462025-04-18Sofwave Medical, Ltd.SofWave SystemPDF
K2437632025-03-12Changsha Anxiang Medical Technology Co…Wireless TENS & EMS Unit—
K2416012025-02-25Cpmt Laser (Canadian Pioneer Medical T…EMS (FlexPulse, MagnaCore, Magnetika)PDF
K2435112025-02-10Changsha Anxiang Medical Technology Co…OTC TENS & EMS Unit—
K2337702025-01-16Pepper Interactive, Inc.Pepper EMS Training SystemPDF
K2427872024-12-18Changsha Anxiang Medical Technology Co…Tens & Ems Device (TU1080)—
K2329822024-11-25Shandong Huamei Technology Co., Ltd.EMS Sculpt MachineFDA
K2421862024-09-17Ofan Intelligent Technology (Guangzhou…Neo Sculptor (OF-NEO001)—
K2416852024-08-07Sofwave Medical, Ltd.SofWave SystemPDF
K2403472024-07-21Zimmer Medizinsysteme GmbHPTG-05PDF
K2307112024-05-16Guangzhou Xinbo Electronic Co., Ltd.Pain Therapy Device(Model: P.T.S-X)—
K2321812024-04-24Hebei JT Medical Co., Ltd.Body Contouring Machine (Models: CS2, CS3, CS5, CS7,…PDF
K2324092024-04-10Shanghai Apolo Medical Technology Co.,…Electromagnetic Stimulation SystemsPDF
K2330702024-03-13Chongqing Rob Linka Science and Techno…Smart Muscle Training Wearables (Model:SM9027,SM9027…—
K2317892024-03-11Guangzhou Xinbo Electronic Co., Ltd.Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)—
K2224002024-02-27K1Med Co., Ltd.Coresculpt & MagsculptFDA
K2330352024-01-08Shenzhen Hengbosi Industrial Co., Ltd.Electronic Muscle Stimulator (Model MP01)—
K2334922023-12-20Xiamen Comfier Technology Co., Ltd.EMS Neck Massager—
K2334702023-12-19El.En S.P.A.DEKA LILYFDA

其中 19 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。