K252334
- 510(k) number
- K252334
- Device name
- PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
- Applicant
- Pontemedag CH
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2026-04-17
- Date received
- 2025-07-28
- 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: K252334.pdf
Official FDA record: K252334
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.