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.

Clearance details

Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
Product code: 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.