Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Everyway Incontinence Stimulation System

K-Number: K161349 · 2017-07-07

ApplicantEveryway Medical Instrument Co., Ltd.
Decision Date2017-07-07
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Everyway Incontinence Stimulation System is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K161349. 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 Everyway Incontinence Stimulation System?

Everyway Incontinence Stimulation System is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Everyway Medical Instrument Co., Ltd.. The 510(k) number is K161349.

When did Everyway Incontinence Stimulation System receive FDA 510(k) clearance?

Everyway Incontinence Stimulation System received FDA 510(k) clearance on 2017-07-07, under 510(k) number K161349.

Who is the listed applicant for Everyway Incontinence Stimulation System?

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

What is the FDA product code for Everyway Incontinence Stimulation System?

The FDA product code for Everyway Incontinence Stimulation System is KPI.

Other records listing Everyway Medical Instrument 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.

K162744Everyway OTC EMS, Model EV-805

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

View on FDA Database →

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

↑