Clearance Summary
Pelvic Floor Exerciser (PF01) received FDA 510(k) clearance under submission number K252748, sponsored by Hunan Accurate Bio-Medical Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2026-04-27.
- Submission: K252748
- Applicant / Sponsor: Hunan Accurate Bio-Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1425
- Decision date: 2026-04-27
Classification & Regulation
This clearance is catalogued under FDA product code HIR and 21 CFR 884.1425, within the Obstetrics/Gynecology review panel as a Class II device.