NGX — Stimulator, Muscle, Powered, For Muscle Conditioning Class II
Classification Details
- Product Code
- NGX
- Device Class
- Class II
- Regulation Number
- 890.5850
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253636 | termosalud s.l | Zionic Pro Max (EMS) | March 12, 2026 |
| K253408 | zimmer medizinsysteme | CoolTone | January 16, 2026 |
| K252154 | guangzhou longest medical technology co | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-232 | December 9, 2025 |
| K253478 | motive health | Motive Muscle Stimulator for Lower Back (OT01-1003) | November 6, 2025 |
| K251594 | syrma johari medtech limited | truFlex | August 28, 2025 |
| K251706 | changsha anxiang medical technology co | TENS and EMS Unit | July 30, 2025 |
| K251378 | zimmer medizinsysteme | CoolTone | July 14, 2025 |
| K251746 | sofwave medical | Pure Impact | July 2, 2025 |
| K250759 | changsha anxiang medical technology co | 3 in 1 TENS UNIT | June 13, 2025 |
| K242926 | xbody hungary kft | XBody Go USA, XBody Pro USA | May 30, 2025 |
| K250038 | zhengzhou pz laser slim technology co | Muscle Stimulator Device (PZ-100) | May 19, 2025 |
| K243165 | eywa | Limfa Therapy System (Limfa Therapy) | May 15, 2025 |
| K250146 | sofwave medical | SofWave System | April 18, 2025 |
| K243763 | changsha anxiang medical technology co | Wireless TENS & EMS Unit | March 12, 2025 |
| K241601 | cpmt laser (canadian pioneer medical technology corporation) | EMS (FlexPulse, MagnaCore, Magnetika) | February 25, 2025 |
| K243511 | changsha anxiang medical technology co | OTC TENS & EMS Unit | February 10, 2025 |
| K233770 | pepper interactive | Pepper EMS Training System | January 16, 2025 |
| K242787 | changsha anxiang medical technology co | Tens & Ems Device (TU1080) | December 18, 2024 |
| K232982 | shandong huamei technology co | EMS Sculpt Machine | November 25, 2024 |
| K242186 | ofan intelligent technology (guangzhou) co. | Neo Sculptor (OF-NEO001) | September 17, 2024 |