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FDA 510(k)

Pelvic Floor Stimulator (Intrelief PFE)

K-Number: K241899 · 2024-11-27

ApplicantEasymed Instruments Co., Ltd.
Decision Date2024-11-27
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pelvic Floor Stimulator (Intrelief PFE) is a medical device manufactured by Easymed Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under approval number K241899. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pelvic Floor Stimulator (Intrelief PFE)?

Pelvic Floor Stimulator (Intrelief PFE) is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Easymed Instruments Co., Ltd.. The 510(k) number is K241899.

When was Pelvic Floor Stimulator (Intrelief PFE) approved by the FDA?

Pelvic Floor Stimulator (Intrelief PFE) received FDA 510(k) clearance on 2024-11-27, under approval number K241899.

What company makes Pelvic Floor Stimulator (Intrelief PFE)?

Pelvic Floor Stimulator (Intrelief PFE) is manufactured by Easymed Instruments Co., Ltd..

What is the FDA product code for Pelvic Floor Stimulator (Intrelief PFE)?

The FDA product code for Pelvic Floor Stimulator (Intrelief PFE) is KPI.

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 Easymed Instruments Co., Ltd.

K211263Intrelief

Related Devices (Code: KPI)

K162010HPM-6000UBTL Industries, Inc. K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15Fuji Dynamics , Ltd. K160773Yarlap IIInternational Trade Group, Inc. K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd. K181497HPM-6000UFBTL Industries, Inc. K171430Incontinence Treatment Device, Model LT2061Shenzhen Dongdixin Technology Co., Ltd.

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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