BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

    K Number: K260453 · Decision Mar 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    2
    Review Days
    29

    Basic Information

    Device Name
    Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
    K Number
    K260453
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionit Labs Srl
    Date Received
    February 11, 2026
    Decision Date
    March 12, 2026
    Product Code
    GXY
    Advisory Committee
    Neurology
    Review Advisory Committee
    PM
    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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