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

    COM-TENS: A NEUROSTIMULATOR

    K Number: K902102 · Decision May 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    6
    Review Days
    387

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    Basic Information

    Device Name
    COM-TENS: A NEUROSTIMULATOR
    K Number
    K902102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Apex Medical, Inc.
    Date Received
    May 8, 1990
    Decision Date
    May 30, 1991
    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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