NGX
162 FDA 510(k) clearances · Product code
174 daysmedian time to decision
385 days90th percentile
162clearances measured
FDA profile
- Official device name
- Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- FDA 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.
- Adverse events (MAUDE)
- 2016: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Diacore (K253926) | ShenB Co., Ltd. | 2026-04-10 |
| Zionic Pro Max (EMS) (K253636) | Termosalud S.L. | 2026-03-12 |
| CoolTone (K253408) | Zimmer Medizinsysteme GmbH | 2026-01-16 |
| Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) (K252154) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-12-09 |
| Motive™ Muscle Stimulator for Lower Back (OT01-1003) (K253478) | Motive Health, Inc. | 2025-11-06 |
| truFlex (K251594) | Syrma Johari Medtech Limited | 2025-08-28 |
| TENS and EMS Unit (K251706) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 |
| CoolTone (K251378) | Zimmer Medizinsysteme GmbH | 2025-07-14 |
| Pure Impact (K251746) | Sofwave Medical, Ltd. | 2025-07-02 |
| 3 in 1 TENS UNIT (K250759) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 |
| XBody Go USA, XBody Pro USA (K242926) | Xbody Hungary Kft. | 2025-05-30 |
| Muscle Stimulator Device (PZ-100) (K250038) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-19 |
| Limfa Therapy System (Limfa Therapy) (K243165) | Eywa Srl | 2025-05-15 |
| SofWave System (K250146) | Sofwave Medical, Ltd. | 2025-04-18 |
| Wireless TENS & EMS Unit (K243763) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-03-12 |
| EMS (FlexPulse, MagnaCore, Magnetika) (K241601) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2025-02-25 |
| OTC TENS & EMS Unit (K243511) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-02-10 |
| Pepper EMS Training System (K233770) | Pepper Interactive, Inc. | 2025-01-16 |
| Tens & Ems Device (TU1080) (K242787) | Changsha Anxiang Medical Technology Co., Ltd. | 2024-12-18 |
| EMS Sculpt Machine (K232982) | Shandong Huamei Technology Co., Ltd. | 2024-11-25 |
| Neo Sculptor (OF-NEO001) (K242186) | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | 2024-09-17 |
| SofWave System (K241685) | Sofwave Medical, Ltd. | 2024-08-07 |
| PTG-05 (K240347) | Zimmer Medizinsysteme GmbH | 2024-07-21 |
| Pain Therapy Device(Model: P.T.S-X) (K230711) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-05-16 |
| Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) (K232181) | Hebei JT Medical Co., Ltd. | 2024-04-24 |
| Electromagnetic Stimulation Systems (K232409) | Shanghai Apolo Medical Technology Co., Ltd. | 2024-04-10 |
| Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) (K233070) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-03-13 |
| Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) (K231789) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-03-11 |
| Coresculpt & Magsculpt (K222400) | K1Med Co., Ltd. | 2024-02-27 |
| Electronic Muscle Stimulator (Model MP01) (K233035) | Shenzhen Hengbosi Industrial Co., Ltd. | 2024-01-08 |
| EMS Neck Massager (K233492) | Xiamen Comfier Technology Co., Ltd. | 2023-12-20 |
| DEKA LILY (K233470) | El.En S.P.A. | 2023-12-19 |
| HI-EMT MAGSHAPE (K230024) | Beijing Sano Laser S&T Development Co.,Ltd | 2023-09-06 |
| Nova HD+ (K220938) | Aura Wellness, LLC | 2023-08-22 |
| Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) (K231318) | Beijing Adss Development Co., Ltd. | 2023-07-07 |
| Fitness Belt (Model: KLT-07) (K231136) | Shenzhen Kelutongda Industrial Co., Ltd. | 2023-06-16 |
| Bemer Therapy System Evo (K231368) | Bemer Int AG | 2023-06-09 |
| Gnesis EMS Plus (K230261) | Creative Fitness Developments S.L. | 2023-06-06 |
| Powered Muscle Stimulator (Model name:MagGraver F200) (K222875) | Nanjing Vishee Medical Technology Co., Ltd. | 2023-03-09 |
| Visionbody (K222386) | Vb Technologies AG | 2023-02-24 |
| Neuro20 Pro System (K223797) | Neuro20 Technologies | 2023-02-23 |
| XBody Go USA, XBody Pro USA (K221200) | Xbody Hungary Kft. | 2023-01-31 |
| truSculpt flex (K212866) | Johari Digital Healthcare Limited | 2022-12-03 |
| CoreLevee (K213748) | Lutronic Corporation | 2022-10-14 |
| Miha Bodytec II (K221498) | Miha Bodytec GmbH | 2022-10-07 |
| WiEMSpro (K211298) | Medical Cables S.L. | 2022-08-25 |
| I-Motion (K212413) | I-Motion Group Global Iberica S.L. | 2022-05-26 |
| CoolTone (K220601) | Zimmer Medizinsysteme GmbH | 2022-04-01 |
| Revitive Medic Coach (Model Number 5575AQ) (K210825) | Actegy , Ltd. | 2021-12-17 |
| Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (K211942) | Shenzhen Osto Technology Company Limited | 2021-12-13 |
| 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) (K212948) | Guangzhou Xinbo Electronic Co., Ltd. | 2021-11-01 |
| Legend Pro DMA (K200545) | Pollogen, Ltd. | 2021-10-21 |
| E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) (K202148) | Fit-Pro , Ltd. | 2021-08-25 |
| Pain Therapy Device (K202638) | Guangzhou Xinbo Electronic Co., Ltd. | 2021-07-15 |
| MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) (K201257) | Arrive Systems, Inc. | 2021-04-06 |
| miha bodytec II (K201975) | Miha Bodytec GmbH | 2021-03-11 |
| SLENDERTONE Evolve Abs, Type 735 (K203513) | Bio-Medical Research, Ltd. | 2021-02-10 |
| BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (K210174) | Bemer Int AG | 2021-02-04 |
| Gymform Total ABS (K202653) | Well Brain International , Ltd. | 2021-01-15 |
| BTL-703-2 (K200382) | Btl | 2021-01-06 |
| NuEra Tight Family, EMS Model (K201239) | Bios S.R.L. | 2020-12-31 |
| TENS & PMS (K201354) | Hong Qiangxing (Shenzhen) Electronics Limited | 2020-12-11 |
| Compex Sport Elite 3.0 (K201653) | Djo, LLC | 2020-11-27 |
| Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) (K201845) | Guangzhou Longest Science & Technology Co., Ltd. | 2020-10-08 |
| Portable Electro-Stimulation Therapy Device (K182020) | Guangzhou Longest Science & Technology Co., Ltd. | 2020-09-17 |
| FitRelief TENS&EMS Wireless Device (K191938) | Heat IN A Click, LLC | 2020-08-28 |
| firefly T-2 (K201131) | Firstkind Limited | 2020-05-28 |
| Revitive Medic Plus, Revitive Advanced 2 (K192887) | Actegy , Ltd. | 2020-05-04 |
| Torc Body (K192039) | Johari Digital Healthcare Limited | 2020-03-29 |
| Katalyst Training System (K190966) | Katalyst, Inc. | 2020-02-03 |
| FastFit EMS System (K192161) | Fast Fit, LLC | 2020-01-22 |
| CoolTone (K192940) | Zimmer Medizinsysteme GmbH | 2019-11-15 |
| HIVOX Spopad EMS SP-911, SP-921 (K192264) | Hivox Biotek, Inc. | 2019-11-08 |
| NXPRO Neuromuscular Electrical Stimulation Device (K191181) | Neux Technologies, Inc. | 2019-10-11 |
| EMS Belt (Model MC0485) (K183103) | Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | 2019-09-18 |
| BionicGym Powered Muscle Stimulator (K182794) | Medical Currents, Ltd. | 2019-07-18 |
| Revitive Medic Plus, Revitive Advanced 2 (K190924) | Actegy , Ltd. | 2019-07-05 |
| BTL 799-2L (K190456) | BTL Industries, Inc. | 2019-07-05 |
| emFieldPro (K182963) | Zimmer Medizinsysteme GmbH | 2019-06-21 |
| Miha Bodytec II (K182519) | Miha Bodytec GmbH | 2019-06-07 |
| FLIX-EMS (K181419) | Casgarum Investment, S.L. | 2019-05-14 |
| Xbody Newave USA (K190038) | Xbody Hungary Kft. | 2019-04-05 |
| Body System (K182440) | A-1 Engineering | 2019-02-26 |
| Tyece OTC EMS System (K183454) | Tyece , Ltd. | 2019-02-26 |
| WiEMSpro (K181955) | Medical Cables S.L. | 2019-02-12 |
| SLENDERTONE CoreFit Abs 8, Type 734 (K180688) | Bio-Medical Research, Ltd. | 2018-10-25 |
| BTL 799-2T (K182106) | BTL Industries, Inc. | 2018-10-23 |
| Muscle Trainer (K181728) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2018-10-17 |
| Katalyst Mark 1 Muscle Stimulation System Model 2 (K181199) | Katalyst, Inc. | 2018-09-20 |
| BTL 799-2 (K180813) | BTL Industries, Inc. | 2018-06-14 |
| Silk'n MODEL H5003 device (K180279) | Home Skinovations , Ltd. | 2018-05-09 |
| PowerDot PD-01M (K172876) | Smartmissimo Technologies Pte, Ltd. | 2017-12-04 |
| Tyece OTC EMS System, Model EM35 (K172241) | Tyece , Ltd. | 2017-11-20 |
| Katalyst Mark 1 Muscle Stimulation System (K171035) | Katalyst, Inc. | 2017-09-06 |
| Everyway OTC EMS, Model EV-805 (K162744) | Everyway Medical Instrument Co., Ltd. | 2017-08-03 |
| XiniWave II Model ECS322P (K171092) | International Trade Group, Inc. | 2017-07-10 |
| Compex Sport Elite (K170918) | Djo, LLC | 2017-06-20 |
| Compex Wireless USA (K170903) | Djo, LLC | 2017-06-19 |
| FlowKeepers (K160323) | Dk Electronics, LLC | 2017-04-06 |
| BEMER Classic Set, BEMER Pro-Set (K151834) | Bemer Int AG | 2017-02-22 |
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