K241533
- 510(k) number
- K241533
- Device name
- NeurAxis IB-Stim (01-1020)
- Applicant
- Neuraxis IN · US
- Product code
- QHH — Non-Implanted Nerve Stimulator For Pain Associated W
- Decision date
- 2024-10-30
- Date received
- 2024-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241533.pdf
Official FDA record: K241533
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.