K231166
- 510(k) number
- K231166
- Device name
- Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
- Applicant
- Zmi Electronics , Ltd. TW
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2024-01-18
- Date received
- 2023-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231166.pdf
Official FDA record: K231166
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.