K250451
- 510(k) number
- K250451
- Device name
- NeurAxis IB-Stim (01-1020)
- Applicant
- Neuraxis IN · US
- Product code
- QHH — Non-Implanted Nerve Stimulator For Pain Associated W
- Decision date
- 2025-05-15
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250451.pdf
Official FDA record: K250451
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.