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510(k) Data Aggregation

    K Number
    K033559
    Device Name
    12-LEAD GLOVE
    Manufacturer
    Date Cleared
    2004-12-22

    (406 days)

    Product Code
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    INEEDMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.
    Device Description
    The 12-Lead Glove has been designed to obtain an electrocardiogram (ECG) with pre-positioned electrodes affixed to the underside of a glove-like sheath. The pre-printed conductive circuity is contained within the sheath (or shell) on a flexible substrate. To obtain the tracing, the operator need only connect the glove via a single (multi-conductor) cable connected to the ECC monitor, slip on the glove, position their hand on the patient's chest, and attach three extendable electrodes which will provide a full 12-Lead recording. The 12-Lead Glove saves valuable time required for set-up compared to the standard approach with multiple electrode placements. It eliminates the confusion of working with the standard cables and eliminates erroneous ECG readings.
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