K260178
- 510(k) number
- K260178
- Device name
- Pelvic Muscle Trainer (KM510, KM516B)
- Applicant
- Shenzhen Konmed Technology Co., Ltd. CN
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2026-06-18
- Date received
- 2026-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260178.pdf
Official FDA record: K260178
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.