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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES

    K Number: K062675 · Decision Jan 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    14
    Review Days
    118

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    Basic Information

    Device Name
    GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
    K Number
    K062675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gemore Technology Co, Ltd.
    Date Received
    September 8, 2006
    Decision Date
    January 4, 2007
    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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    K102933 GEM-TONE BODY TRAINING SYSTEM
    K102926 GEMORE MUSCLE CONDITIONER;
    K091833 GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.
    K060222 LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
    K042559 GEM-TWIN TENS/ MODELS GM3XY/Z
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