K230767
- 510(k) number
- K230767
- Device name
- Pelvic Floor Muscle Stimulator
- Applicant
- Nanjing Vishee Medical Technology Co., Ltd. CN
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2023-09-21
- Date received
- 2023-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230767.pdf
Official FDA record: K230767
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.