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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 a medical device manufactured by Hunan Accurate Bio-Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-27 under approval 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. It is manufactured by Hunan Accurate Bio-Medical Technology Co., Ltd.. The 510(k) number is K252748.

When was Pelvic Floor Exerciser (PF01) approved by the FDA?

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

What company makes Pelvic Floor Exerciser (PF01)?

Pelvic Floor Exerciser (PF01) is manufactured by Hunan Accurate Bio-Medical Technology Co., Ltd..

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

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

Related Clinical Trials

NCT07534696 Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy ENROLLING_BY_INVITATION NCT07592403 Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis RECRUITING NCT07574268 Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial COMPLETED NCT06251557 Core Massage and Exercise in Pediatric LUTD COMPLETED NCT07554612 The Impact of Trunk and Lower Extremity Electrical Stimulation on Pelvic Floor Muscle Strength in Females RECRUITING NCT05952258 Magnetic Stimulation as a Treatment for Stress Urinary Incontinence ENROLLING_BY_INVITATION

Other Devices by Hunan Accurate Bio-Medical Technology Co., Ltd.

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

Related Devices (Code: HIR)

K160758PeriCoach OTCAnalytica, Ltd. K171896Feminine Personal Trainer (FPT)Ralston Group K162689Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. K180637leva Pelvic Floor TrainerRenovia, Inc. K192270LEva Pelvic Digital Health SystemRenovia, Inc. K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose

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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