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

    KM-10 TENS ELECTRODE

    K Number: K000870 · Decision Nov 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    26
    Review Days
    232

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    Basic Information

    Device Name
    KM-10 TENS ELECTRODE
    K Number
    K000870
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Katecho, Inc.
    Date Received
    March 20, 2000
    Decision Date
    November 7, 2000
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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    Other Clearances by Katecho, Inc.

    K Number Device Name
    K012404 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
    K010543 KM-30 TENS ELECTRODE
    K003228 K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
    K002806 K-DEFIB/PACE, MODEL KDP-60A
    K993745 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
    K991007 K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
    K981737 K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
    K954504 K-DEFIB/PACE PEDIATRIC ELECTRODE
    K934692 K-DEFIB/PACE PEDIATRIC ELECTRODE
    K940801 K-KLIP
    Search all 26 clearances from Katecho, Inc. →