K252552
- 510(k) number
- K252552
- Device name
- Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
- Applicant
- Shenzhen Changkun Technology Co., Ltd. CN
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2026-05-06
- Date received
- 2025-08-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252552.pdf
Official FDA record: K252552
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.