K252024
- 510(k) number
- K252024
- Device name
- NeurAxis IB-Stim (01-1020)
- Applicant
- Neuraxis IN · US
- Product code
- QHH — Non-Implanted Nerve Stimulator For Pain Associated W
- Decision date
- 2025-10-16
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K252024.pdf
Official FDA record: K252024
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.