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NGX

Stimulator, Muscle, Powered, For Muscle Conditioning

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)
33
Summaries archived here
19 (direct download)
510(k) clearances (all years, FDA)
163 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (33)

Last three years. Most recent: 2026-08-13.

NumberDecision dateApplicantDevice nameSummary
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

19 summaries are archived here for direct download.

Official FDA classification page: NGX
Classification and pathway per current FDA publications. Data from openFDA (CC0).