K251429
- 510(k) number
- K251429
- Device name
- OTC 4-Channel Rechargeable TENS Unit
- Applicant
- Changsha Anxiang Medical Technology Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2025-08-28
- Date received
- 2025-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251429
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.