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

    Migraine Tens Digital Pain Reliever

    K Number: K210364 · Decision Jun 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    25
    Review Days
    129

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    Basic Information

    Device Name
    Migraine Tens Digital Pain Reliever
    K Number
    K210364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5891
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    February 8, 2021
    Decision Date
    June 17, 2021
    Product Code
    PCC
    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
    PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

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