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510(k) Data Aggregation

    K Number
    K954951
    Device Name
    TAYLOR GENERAL PURPOSE MONITORING ELECTRODE
    Date Cleared
    1996-05-30

    (213 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAYLOR INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Taylor TENS electrode is designed to be used in monitoring applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance, which can cause the pickup of 60 cycle neise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures. The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only.
    Device Description
    The Taylor TENS Electrode is intended to be used as an ECG or stimulating electrode. The electrode is a Silver/ Silver Chioride conductive coated carbon filled polymer, with an attached leadware. The adhesive that is being used is a hypo-allergenic hydrogel which allows for an adequate hold to the patient. This product meets all of the applicable AAM Standards.
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