K251187
- 510(k) number
- K251187
- Device name
- 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
- Applicant
- Changsha Anxiang Medical Technology Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2025-07-28
- Date received
- 2025-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251187
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.