BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Everyway Incontinence Stimulation System

    K Number: K213116 · Decision Dec 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    29
    Review Days
    67

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    Basic Information

    Device Name
    Everyway Incontinence Stimulation System
    K Number
    K213116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Everyway Medical Instruments Co.,Ltd
    Date Received
    September 27, 2021
    Decision Date
    December 3, 2021
    Product Code
    KPI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Everyway Medical Instruments Co.,Ltd

    K Number Device Name
    K251856 Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
    K222488 Everyway Analog OTC TENS
    K202849 Everyway Analog OTC TENS, model N103A/N302
    K202470 Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
    K202317 Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
    K201335 Li-Battery powered OTC TENS/EMS Combination Stimulator
    K192589 Everyway OTC TENS/EMS Combination
    K182767 V2 OTC Pain Relief TENS
    K182753 A6 OTC Pain Relief TENS
    K181707 Everyway Wireless TENS & EMS Unit
    Search all 29 clearances from Everyway Medical Instruments Co.,Ltd →