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510(k) Data Aggregation

    K Number
    K152056
    Device Name
    Winco Model S550 Stretchair
    Manufacturer
    WINCO MANUFACTURING LLC
    Date Cleared
    2016-04-11

    (262 days)

    Product Code
    INK
    Regulation Number
    890.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    WINCO MANUFACTURING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Winco Model S550 Stretchair is to provide a method of transporting patients within healthcare facilities.
    Device Description
    The Winco Model S550 Stretchair is a battery powered device designed for use in healthcare facilities. Its' intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility. The Winco Model S550 Stretchair has a powered height adjustment feature which allows patient surface to be raised and lowered for patient mounting and patient access. It also has a powered linear actuator which changes the patient surface from a sitting position to a laying (supine) position. The patient can be transported only when in the seated position. When in the supine position, it can be used to transfer a patient to/from a bed, gurney or other patient support surface. The Winco Model S550 Stretchair is for patients weighing up to 550 Ibs. It is intended for indoor use only, by trained medical staff and health care personnel. There is no drive mechanism or power assist for moving the product from one physical location to another. This is performed manually by the medical staff. The device cannot be self-propelled by the patient.
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