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

    Wrap Accessory Electrodes

    K Number: K210383 · Decision Nov 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    6
    Review Days
    276

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    Basic Information

    Device Name
    Wrap Accessory Electrodes
    K Number
    K210383
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hi-Dow International, Inc.
    Date Received
    February 9, 2021
    Decision Date
    November 12, 2021
    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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