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FDA 510(k)

Pelvic Floor Exerciser (PF01)

K-Number: K252748 · 2026-04-27

ApplicantHunan Accurate Bio-Medical Technology Co., Ltd.
Decision Date2026-04-27
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Pelvic Floor Exerciser (PF01) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-27 under 510(k) number K252748. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pelvic Floor Exerciser (PF01)?

Pelvic Floor Exerciser (PF01) is a medical device that received FDA 510(k) clearance on 2026-04-27. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. The 510(k) number is K252748.

When did Pelvic Floor Exerciser (PF01) receive FDA 510(k) clearance?

Pelvic Floor Exerciser (PF01) received FDA 510(k) clearance on 2026-04-27, under 510(k) number K252748.

Who is the listed applicant for Pelvic Floor Exerciser (PF01)?

The FDA 510(k) record lists Hunan Accurate Bio-Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pelvic Floor Exerciser (PF01)?

The FDA product code for Pelvic Floor Exerciser (PF01) is HIR.

Other records listing Hunan Accurate Bio-Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)K240808Pulse Oximeter (WS20A)K171241Pulse Oximeter

Related Devices (Code: HIR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 InnovationsK213913leva Pelvic Health SystemRenovia, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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