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

    QUADRA BLOC TENS PLUS

    K Number: K102278 · Decision Oct 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    2
    Review Days
    435

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    Basic Information

    Device Name
    QUADRA BLOC TENS PLUS
    K Number
    K102278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gradient Technologies, LLC
    Date Received
    August 11, 2010
    Decision Date
    October 20, 2011
    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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    Other Clearances by Gradient Technologies, LLC

    K Number Device Name
    K062547 QUADRA BLOC TENS, MODEL 101