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

    DR-HO'S Electro Therapy Conductive Gel

    K Number: K200402 · Decision Nov 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    68
    Applicant Total
    12
    Review Days
    280

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    Basic Information

    Device Name
    DR-HO'S Electro Therapy Conductive Gel
    K Number
    K200402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1275
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Xinbo Electronic Co., Ltd.
    Date Received
    February 19, 2020
    Decision Date
    November 25, 2020
    Product Code
    GYB
    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
    GYB Media, Electroconductive

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    Other Clearances by Guangzhou Xinbo Electronic Co., Ltd.

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    Search all 12 clearances from Guangzhou Xinbo Electronic Co., Ltd. →