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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 the device name listed in this FDA 510(k) record. The listed applicant is Easymed Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) 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. The listed applicant is Easymed Instruments Co., Ltd.. The 510(k) number is K241899.

When did Pelvic Floor Stimulator (Intrelief PFE) receive FDA 510(k) clearance?

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

Who is the listed applicant for Pelvic Floor Stimulator (Intrelief PFE)?

The FDA 510(k) record lists Easymed Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07574268Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled TrialCOMPLETED

Other records listing Easymed Instruments 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.

K211263Intrelief

Related Devices (Code: KPI)

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.

K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)PontemedagK251760Well-Life Incontinence Stimulation System (WL-2405i(P))Well-Life Healthcare , Ltd.

Official Source

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

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