BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ZIDA Wearable Neuromodulation System

    K Number: K192731 · Decision Mar 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    539

    Basic Information

    Device Name
    ZIDA Wearable Neuromodulation System
    K Number
    K192731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5310
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exodus Innovations
    Date Received
    September 27, 2019
    Decision Date
    March 19, 2021
    Product Code
    NAM
    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
    NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

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