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

    Tutamen Self Adhesive Electrodes

    K Number: K252439 · Decision May 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    2
    Review Days
    270

    Basic Information

    Device Name
    Tutamen Self Adhesive Electrodes
    K Number
    K252439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan Tutamen Metalwork Co., Ltd.
    Date Received
    August 4, 2025
    Decision Date
    May 1, 2026
    Product Code
    GXY
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXY Electrode, Cutaneous

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