TENS and EMS Unit
FDA 510(k) K251706 · Changsha Anxiang Medical Technology Co., Ltd.
Submission
- Device name
- TENS and EMS Unit
- Applicant
- Changsha Anxiang Medical Technology Co., Ltd.
Changsha, CN - Received
- June 3, 2025
- Decision date
- July 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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…
Other 510(k)s with product code NGX
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|---|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60)NGX · Traditional | Beijing Winkonlaser Technology Limited | 08/13/2026SE |
| K253926 | DiacoreNGX · Traditional | ShenB Co., Ltd. | 04/10/2026SE |
| K253636 | Zionic Pro Max (EMS)NGX · Traditional | Termosalud S.L. | 03/12/2026SE |
| K253408 | CoolToneNGX · Traditional | Zimmer Medizinsysteme GmbH | 01/16/2026SE |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)NGX · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 12/09/2025SE |
| K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003)NGX · Traditional | Motive Health, Inc. | 11/06/2025SE |
| K251594 | truFlexNGX · Special | Syrma Johari Medtech Limited | 08/28/2025SE |
| K251378 | CoolToneNGX · Special | Zimmer Medizinsysteme GmbH | 07/14/2025SE |
| K251746 | Pure ImpactNGX · Special | Sofwave Medical, Ltd. | 07/02/2025SE |
| K250759 | 3 in 1 TENS UNITNGX · Traditional | Changsha Anxiang Medical Technology Co., Ltd. | 06/13/2025SE |
More from Changsha Anxiang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251429 | OTC 4-Channel Rechargeable TENS UnitNUH · Special | 08/28/2025SE |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)NUH · Traditional | 07/28/2025SE |
| K250759 | 3 in 1 TENS UNITNGX · Traditional | 06/13/2025SE |
| K243763 | Wireless TENS & EMS UnitNGX · Traditional | 03/12/2025SE |
| K243511 | OTC TENS & EMS UnitNGX · Traditional | 02/10/2025SE |
| K242787 | Tens & Ems Device (TU1080)NGX · Traditional | 12/18/2024SE |
| K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS…NUH · Traditional | 11/04/2024SE |
Questions and answers
When was TENS and EMS Unit cleared by the FDA?
TENS and EMS Unit (K251706) received a 510(k) decision of Substantially Equivalent on July 30, 2025, 57 days after the submission was received.
What is the product code of K251706?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.