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

    AUTO-TENS MODEL V

    K Number: K832337 · Decision Aug 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    5
    Review Days
    44

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    Basic Information

    Device Name
    AUTO-TENS MODEL V
    K Number
    K832337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Cbc Corp.
    Date Received
    July 18, 1983
    Decision Date
    August 31, 1983
    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 Cbc Corp.

    K Number Device Name
    K823466 AUTO-TENS MODEL III DUAL CHANNEL REPLACE
    K823467 AUTO-TENS MODEL I DISPOS. SINGLE CHAN
    K823465 AUTO-TENS MODEL II SINGLE CHANNEL
    K823464 AUTO-TENS MODEL IV -DUAL CHANNEL FULL