NGX · Stimulator, Muscle, Powered, For Muscle Conditioning
Physical Medicine · 21 CFR 890.5850 · Class 2
Overview
| Product Code | NGX |
|---|---|
| Device Name | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 162)
Showing 20 most recent of 162 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253926 | Diacore | ShenB Co., Ltd. | Apr 10, 2026 | SESE |
| K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | Mar 12, 2026 | SESE |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH | Jan 16, 2026 | SESE |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | Dec 9, 2025 | SESE |
| K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | Nov 6, 2025 | SESE |
| K251594 | truFlex | Syrma Johari Medtech Limited | Aug 28, 2025 | SESE |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | Jul 30, 2025 | SESE |
| K251378 | CoolTone | Zimmer Medizinsysteme GmbH | Jul 14, 2025 | SESE |
| K251746 | Pure Impact | Sofwave Medical, Ltd. | Jul 2, 2025 | SESE |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | Jun 13, 2025 | SESE |
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | May 30, 2025 | SESE |
| K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | May 19, 2025 | SESE |
| K243165 | Limfa Therapy System (Limfa Therapy) | Eywa Srl | May 15, 2025 | SESE |
| K250146 | SofWave System | Sofwave Medical, Ltd. | Apr 18, 2025 | SESE |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | Mar 12, 2025 | SESE |
| K241601 | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | Feb 25, 2025 | SESE |
| K243511 | OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | Feb 10, 2025 | SESE |
| K233770 | Pepper EMS Training System | Pepper Interactive, Inc. | Jan 16, 2025 | SESE |
| K242787 | Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd. | Dec 18, 2024 | SESE |
| K232982 | EMS Sculpt Machine | Shandong Huamei Technology Co., Ltd. | Nov 25, 2024 | SESE |
Top Applicants
- Bio-Medical Research, Ltd. — 13 clearances
- Zimmer Medizinsysteme GmbH — 6 clearances
- Actegy , Ltd. — 5 clearances
- Changsha Anxiang Medical Technology Co., Ltd. — 5 clearances
- BTL Industries, Inc. — 4 clearances
