Pelvic Floor Exerciser (PF01)— 510(k) K252748

Name: FDA 510(k) clearance K252748
Creator: U.S. Food and Drug Administration
Published: 2026-04-27

Substantially Equivalent

Hunan Accurate Bio-Medical Technology Co., Ltd.

FDA 510(k) clearance K252748 for Pelvic Floor Exerciser (PF01), Substantially Equivalent on 2026-04-27. Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.. Device class: 2.

Summary

Hunan Accurate Bio-Medical Technology's Pelvic Floor Exerciser (model PF01) is filed under product code HIR (Perineometer).

Class II, 21 CFR 884.1425. The record lists Obstetrics/Gynecology as the classification panel, but the Gastroenterology and Urology review panel handled this Traditional 510(k).

Hunan Accurate Bio-Medical Technology filed from Changsha, China. Review took 241 calendar days (August 29, 2025 to April 27, 2026).

Clearance details

Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
Product code: Product code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 2025-08-29
Decision date: 2026-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.