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510(k) Data Aggregation

    K Number
    K071576
    Device Name
    TEXTRONICS ECG ELECTRODE
    Manufacturer
    Date Cleared
    2007-11-02

    (147 days)

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

    TEXTRONICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Textronics™ ECG Electrode is intended for use in general electrocardiograph monitoring and recording procedures. The Textronics™ ECG Electrode is indicated for use with most ECG instruments on the market. It is indicated for applications including resting ECGs, exercise ECGs, and/or ambulatory monitoring. The device is indicated for both prescription and over-the-counter use.
    Device Description
    The Textronics ™ ECG Electrode consists of electrodes, an exterior housing for the electrodes that makes contact with the patient, and a means of connecting the device to an ECG instrument. The Textronics™ ECG Electrode has textilebased electrodes made of electrically conductive yarns knitted together with electrically non-conductive yarns. The conductive yarns are silver coated polyamide (nylon). The non-conductive yarns can include cotton, spandex, polyester, and/or nylon. The Textronics™ ECG Electrode's textile-based electrodes have an exterior housing made of fabric, which can be made out of common textile materials, including polypropylene, nylon, Lycra® Spandex, polyester, and/or cotton. This fabric exterior housing can take the shape of a variety of garments, such as chest straps, wrist bands, shirts, bras, or vests. The Textronics™ ECG Electrode connects to ECG instruments via a conductive snap.
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