Data / Medical devices / China / Changsha Anxiang Medical Technology Co., LTD
Changsha Anxiang Medical Technology Co., LTD: FDA-registered device maker in Changsha Hunan, China, 9 510(k) clearances
Changsha Anxiang Medical Technology Co., LTD is registered with the FDA (registration 3017887847) in Changsha Hunan, China. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 28, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3017887847
- Address
- 9th Floor, R&D Center and Supporting Projects 101, No. 18 Shaoshan Middle Road, Dongtang Street Yuhua District, Changsha Hunan, China, 410000
- Owner or operator
- Changsha Anxiang Medical Technology Co., LTD (10079329)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 28, 2023
- Registered through
- 2027
- Brand names listed
- 3 in 1 TENS UNIT, model TC1241, 3 in 1 TENS UNIT, model TC2241, 3 in 1 TENS UNIT, model TS2301, 3 in 1 TENS UNIT, model TS2321, Muscle and Nerve Stimulator TENS & EMS , model TP2208C, Muscle and Nerve Stimulator TENS & EMS , model TP2208, OTC 4-Channel Rechargeable TENS Unit, model TP2408C, OTC TENS & EMS Unit, model TA2224 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 28, 2025 | K251429 | OTC 4-Channel Rechargeable TENS Unit | NUH | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 30, 2025 | K251706 | TENS and EMS Unit | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 28, 2025 | K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | NUH | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 13, 2025 | K250759 | 3 in 1 TENS UNIT | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 12, 2025 | K243763 | Wireless TENS & EMS Unit | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 10, 2025 | K243511 | OTC TENS & EMS Unit | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 18, 2024 | K242787 | Tens & Ems Device (TU1080) | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 4, 2024 | K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | NUH | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 10, 2023 | K230164 | TENS and EMS Stimulation (OTC) | NUH | Substantially Equivalent | Changsha Yuwen Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
Updated August 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.