K241862
- 510(k) number
- K241862
- Device name
- Levina Pelvic Floor Muscle Stimulator (RS-48)
- Applicant
- Zmi Electronics , Ltd. TW
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2025-03-27
- Date received
- 2024-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241862.pdf
Official FDA record: K241862
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.