FDA Product Code
FDA Product Code NGX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5850
510(k) Clearances — 163 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | 2026-08-13 | Traditional | PDF ↗ |
| K253926 | Diacore | ShenB Co., Ltd. | 2026-04-10 | Traditional | PDF ↗ |
| K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | 2026-03-12 | Traditional | PDF ↗ |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026-01-16 | Traditional | PDF ↗ |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-12-09 | Traditional | PDF ↗ |
| K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | 2025-11-06 | Traditional | PDF ↗ |
| K251594 | truFlex | Syrma Johari Medtech Limited | 2025-08-28 | Special | PDF ↗ |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 | Special | PDF ↗ |
| K251378 | CoolTone | Zimmer Medizinsysteme GmbH | 2025-07-14 | Special | PDF ↗ |
| K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025-07-02 | Special | PDF ↗ |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 | Traditional | PDF ↗ |
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025-05-30 | Traditional | PDF ↗ |
| K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-19 | Traditional | PDF ↗ |
| K243165 | Limfa Therapy System (Limfa Therapy) | Eywa Srl | 2025-05-15 | Traditional | PDF ↗ |
| K250146 | SofWave System | Sofwave Medical, Ltd. | 2025-04-18 | Traditional | PDF ↗ |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-03-12 | Traditional | PDF ↗ |
| K241601 | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2025-02-25 | Traditional | PDF ↗ |
| K243511 | OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-02-10 | Traditional | PDF ↗ |
| K233770 | Pepper EMS Training System | Pepper Interactive, Inc. | 2025-01-16 | Traditional | PDF ↗ |
| K242787 | Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd. | 2024-12-18 | Traditional | PDF ↗ |
| K232982 | EMS Sculpt Machine | Shandong Huamei Technology Co., Ltd. | 2024-11-25 | Traditional | PDF ↗ |
| K242186 | Neo Sculptor (OF-NEO001) | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | 2024-09-17 | Traditional | PDF ↗ |
| K241685 | SofWave System | Sofwave Medical, Ltd. | 2024-08-07 | Traditional | PDF ↗ |
| K240347 | PTG-05 | Zimmer Medizinsysteme GmbH | 2024-07-21 | Traditional | PDF ↗ |
| K230711 | Pain Therapy Device(Model: P.T.S-X) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-05-16 | Traditional | PDF ↗ |
| K232181 | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) | Hebei JT Medical Co., Ltd. | 2024-04-24 | Traditional | PDF ↗ |
| K232409 | Electromagnetic Stimulation Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2024-04-10 | Traditional | PDF ↗ |
| K233070 | Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-03-13 | Traditional | PDF ↗ |
| K231789 | Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-03-11 | Traditional | PDF ↗ |
| K222400 | Coresculpt & Magsculpt | K1Med Co., Ltd. | 2024-02-27 | Traditional | PDF ↗ |
| K233035 | Electronic Muscle Stimulator (Model MP01) | Shenzhen Hengbosi Industrial Co., Ltd. | 2024-01-08 | Traditional | PDF ↗ |
| K233492 | EMS Neck Massager | Xiamen Comfier Technology Co., Ltd. | 2023-12-20 | Traditional | PDF ↗ |
| K233470 | DEKA LILY | El.En S.P.A. | 2023-12-19 | Traditional | PDF ↗ |
| K230024 | HI-EMT MAGSHAPE | Beijing Sano Laser S&T Development Co.,Ltd | 2023-09-06 | Traditional | PDF ↗ |
| K220938 | Nova HD+ | Aura Wellness, LLC | 2023-08-22 | Traditional | PDF ↗ |
| K231318 | Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) | Beijing Adss Development Co., Ltd. | 2023-07-07 | Traditional | PDF ↗ |
| K231136 | Fitness Belt (Model: KLT-07) | Shenzhen Kelutongda Industrial Co., Ltd. | 2023-06-16 | Traditional | PDF ↗ |
| K231368 | Bemer Therapy System Evo | Bemer Int AG | 2023-06-09 | Traditional | PDF ↗ |
| K230261 | Gnesis EMS Plus | Creative Fitness Developments S.L. | 2023-06-06 | Traditional | PDF ↗ |
| K222875 | Powered Muscle Stimulator (Model name:MagGraver F200) | Nanjing Vishee Medical Technology Co., Ltd. | 2023-03-09 | Traditional | PDF ↗ |
| K222386 | Visionbody | Vb Technologies AG | 2023-02-24 | Traditional | PDF ↗ |
| K223797 | Neuro20 Pro System | Neuro20 Technologies | 2023-02-23 | Traditional | PDF ↗ |
| K221200 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2023-01-31 | Traditional | PDF ↗ |
| K212866 | truSculpt flex | Johari Digital Healthcare Limited | 2022-12-03 | Traditional | PDF ↗ |
| K213748 | CoreLevee | Lutronic Corporation | 2022-10-14 | Traditional | PDF ↗ |
| K221498 | Miha Bodytec II | Miha Bodytec GmbH | 2022-10-07 | Traditional | PDF ↗ |
| K211298 | WiEMSpro | Medical Cables S.L. | 2022-08-25 | Traditional | PDF ↗ |
| K212413 | I-Motion | I-Motion Group Global Iberica S.L. | 2022-05-26 | Traditional | PDF ↗ |
| K220601 | CoolTone | Zimmer Medizinsysteme GmbH | 2022-04-01 | Special | PDF ↗ |
| K210825 | Revitive Medic Coach (Model Number 5575AQ) | Actegy , Ltd. | 2021-12-17 | Traditional | PDF ↗ |
| K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | Shenzhen Osto Technology Company Limited | 2021-12-13 | Traditional | PDF ↗ |
| K212948 | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) | Guangzhou Xinbo Electronic Co., Ltd. | 2021-11-01 | Traditional | PDF ↗ |
| K200545 | Legend Pro DMA | Pollogen, Ltd. | 2021-10-21 | Traditional | PDF ↗ |
| K202148 | E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) | Fit-Pro , Ltd. | 2021-08-25 | Traditional | PDF ↗ |
| K202638 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | 2021-07-15 | Traditional | PDF ↗ |
| K201257 | MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) | Arrive Systems, Inc. | 2021-04-06 | Traditional | PDF ↗ |
| K201975 | miha bodytec II | Miha Bodytec GmbH | 2021-03-11 | Traditional | PDF ↗ |
| K203513 | SLENDERTONE Evolve Abs, Type 735 | Bio-Medical Research, Ltd. | 2021-02-10 | Special | PDF ↗ |
| K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2021-02-04 | Traditional | PDF ↗ |
| K202653 | Gymform Total ABS | Well Brain International , Ltd. | 2021-01-15 | Traditional | PDF ↗ |
| K200382 | BTL-703-2 | Btl | 2021-01-06 | Traditional | PDF ↗ |
| K201239 | NuEra Tight Family, EMS Model | Bios S.R.L. | 2020-12-31 | Traditional | PDF ↗ |
| K201354 | TENS & PMS | Hong Qiangxing (Shenzhen) Electronics Limited | 2020-12-11 | Traditional | PDF ↗ |
| K201653 | Compex Sport Elite 3.0 | Djo, LLC | 2020-11-27 | Traditional | PDF ↗ |
| K201845 | Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) | Guangzhou Longest Science & Technology Co., Ltd. | 2020-10-08 | Traditional | PDF ↗ |
| K182020 | Portable Electro-Stimulation Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. | 2020-09-17 | Traditional | PDF ↗ |
| K191938 | FitRelief TENS&EMS Wireless Device | Heat IN A Click, LLC | 2020-08-28 | Traditional | PDF ↗ |
| K201131 | firefly T-2 | Firstkind Limited | 2020-05-28 | Special | PDF ↗ |
| K192887 | Revitive Medic Plus, Revitive Advanced 2 | Actegy , Ltd. | 2020-05-04 | Traditional | PDF ↗ |
| K192039 | Torc Body | Johari Digital Healthcare Limited | 2020-03-29 | Traditional | PDF ↗ |
| K190966 | Katalyst Training System | Katalyst, Inc. | 2020-02-03 | Traditional | PDF ↗ |
| K192161 | FastFit EMS System | Fast Fit, LLC | 2020-01-22 | Traditional | PDF ↗ |
| K192940 | CoolTone | Zimmer Medizinsysteme GmbH | 2019-11-15 | Special | PDF ↗ |
| K192264 | HIVOX Spopad EMS SP-911, SP-921 | Hivox Biotek, Inc. | 2019-11-08 | Special | PDF ↗ |
| K191181 | NXPRO Neuromuscular Electrical Stimulation Device | Neux Technologies, Inc. | 2019-10-11 | Traditional | PDF ↗ |
| K183103 | EMS Belt (Model MC0485) | Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | 2019-09-18 | Traditional | PDF ↗ |
| K182794 | BionicGym Powered Muscle Stimulator | Medical Currents, Ltd. | 2019-07-18 | Traditional | PDF ↗ |
| K190924 | Revitive Medic Plus, Revitive Advanced 2 | Actegy , Ltd. | 2019-07-05 | Traditional | PDF ↗ |
| K190456 | BTL 799-2L | BTL Industries, Inc. | 2019-07-05 | Traditional | PDF ↗ |
| K182963 | emFieldPro | Zimmer Medizinsysteme GmbH | 2019-06-21 | Traditional | PDF ↗ |
| K182519 | Miha Bodytec II | Miha Bodytec GmbH | 2019-06-07 | Traditional | PDF ↗ |
| K181419 | FLIX-EMS | Casgarum Investment, S.L. | 2019-05-14 | Traditional | PDF ↗ |
| K190038 | Xbody Newave USA | Xbody Hungary Kft. | 2019-04-05 | Traditional | PDF ↗ |
| K183454 | Tyece OTC EMS System | Tyece , Ltd. | 2019-02-26 | Traditional | PDF ↗ |
| K182440 | Body System | A-1 Engineering | 2019-02-26 | Traditional | PDF ↗ |
| K181955 | WiEMSpro | Medical Cables S.L. | 2019-02-12 | Traditional | PDF ↗ |
| K180688 | SLENDERTONE CoreFit Abs 8, Type 734 | Bio-Medical Research, Ltd. | 2018-10-25 | Traditional | PDF ↗ |
| K182106 | BTL 799-2T | BTL Industries, Inc. | 2018-10-23 | Traditional | PDF ↗ |
| K181728 | Muscle Trainer | Shenzhen Kentro Medical Electronics Co., Ltd. | 2018-10-17 | Traditional | PDF ↗ |
| K181199 | Katalyst Mark 1 Muscle Stimulation System Model 2 | Katalyst, Inc. | 2018-09-20 | Traditional | PDF ↗ |
| K180813 | BTL 799-2 | BTL Industries, Inc. | 2018-06-14 | Traditional | PDF ↗ |
| K180279 | Silk'n MODEL H5003 device | Home Skinovations , Ltd. | 2018-05-09 | Traditional | PDF ↗ |
| K172876 | PowerDot PD-01M | Smartmissimo Technologies Pte, Ltd. | 2017-12-04 | Special | PDF ↗ |
| K172241 | Tyece OTC EMS System, Model EM35 | Tyece , Ltd. | 2017-11-20 | Traditional | PDF ↗ |
| K171035 | Katalyst Mark 1 Muscle Stimulation System | Katalyst, Inc. | 2017-09-06 | Traditional | PDF ↗ |
| K162744 | Everyway OTC EMS, Model EV-805 | Everyway Medical Instrument Co., Ltd. | 2017-08-03 | Traditional | PDF ↗ |
| K171092 | XiniWave II Model ECS322P | International Trade Group, Inc. | 2017-07-10 | Traditional | PDF ↗ |
| K170918 | Compex Sport Elite | Djo, LLC | 2017-06-20 | Traditional | PDF ↗ |
| K170903 | Compex Wireless USA | Djo, LLC | 2017-06-19 | Traditional | PDF ↗ |
| K160323 | FlowKeepers | Dk Electronics, LLC | 2017-04-06 | Traditional | PDF ↗ |
Product code NGX · Class II · Physical Medicine. Data: openFDA.