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510(k) Data Aggregation

    K Number
    K090496
    Device Name
    QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
    Date Cleared
    2009-09-01

    (188 days)

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

    CARDIAC LEAD TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Qwiklead™ Electrocardiograph Electrode Patch is intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include, in particular, patient ECG surveillance and ECG diagnosis recording. The Qwiklead™ Electrocardiograph Electrode Patch is intended for single-patient/single application use and is intended to be used on intact (uninjured) skin. The Qwiklead™ Electrocardiograph Electrode Patch is to be used on adults.
    Device Description
    The Qwiklead™ Electrocardiograph Electrode Patch configures pre-positioned ECG electrodes affixed to the underside of a single non-sterile, laminated, flexible patch/pad. The patch is a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate) including at least one electrode, a second layer (metallic with Ag/AgCl coating) that contains the electrodes, and a third layer (made of biocompatible conductive hydrogel coupling media). The patch is placed on the patient's chest, and no additional electrodes need be placed on the patient's limbs, as is typical for ECG electrodes.
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