K252688
- 510(k) number
- K252688
- Device name
- Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
- Applicant
- Bozhou Rongjian Medical Appliance Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2025-11-24
- Date received
- 2025-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252688.pdf
Official FDA record: K252688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.