K252748
- 510(k) number
- K252748
- Device name
- Pelvic Floor Exerciser (PF01)
- Applicant
- Hunan Accurate Bio-Medical Technology Co., Ltd. CN
- Product code
- HIR — Perineometer
- Decision date
- 2026-04-27
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252748.pdf
Official FDA record: K252748
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.