BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Elitone for Men

    K Number: K253285 · Decision Jan 23, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    116

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    Basic Information

    Device Name
    Elitone for Men
    K Number
    K253285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5330
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elidah, Inc.
    Date Received
    September 29, 2025
    Decision Date
    January 23, 2026
    Product Code
    QAJ
    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
    QAJ Cutaneous Electrode Stimulator For Urinary Incontinence

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    Other Clearances by Elidah, Inc.

    K Number Device Name
    K223884 ELITONE Urge Urinary Incontinence Device
    K183585 Elitone Device