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

    INDICATENS 4X4

    K Number: K881708 · Decision Aug 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    7
    Review Days
    113

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    Basic Information

    Device Name
    INDICATENS 4X4
    K Number
    K881708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Acudata Software
    Date Received
    April 20, 1988
    Decision Date
    August 11, 1988
    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 Acudata Software

    K Number Device Name
    K900596 ACUDATA INDICATENS MODEL 5A
    K900668 ACUDATA INDICATENS MODEL 5XS
    K890087 ACUDATA INDICATENS MODEL 5M
    K890088 ACUDATA INDICATENS MODEL 5X
    K891105 INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES
    K891107 INDICATENS INDICATOR ELECTRODE MODEL 2