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

    EXTRA TENS (RI-2500) NEO TENS (RI-2000E)

    K Number: K963507 · Decision Mar 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    1
    Review Days
    197

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    Basic Information

    Device Name
    EXTRA TENS (RI-2500) NEO TENS (RI-2000E)
    K Number
    K963507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Comtek Intl., Corp.
    Date Received
    September 3, 1996
    Decision Date
    March 19, 1997
    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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