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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    SANIDAD TENS-DUO MODE GP8016N

    K Number: K021430 · Decision Dec 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    4
    Review Days
    213

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    Basic Information

    Device Name
    SANIDAD TENS-DUO MODE GP8016N
    K Number
    K021430
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rolor Electronics Corp.
    Date Received
    May 3, 2002
    Decision Date
    December 2, 2002
    Product Code
    GZJ
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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