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510(k) Data Aggregation

    K Number
    K111095
    Device Name
    BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025
    Date Cleared
    2011-08-03

    (105 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRO KINETIC TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BREEZ Electric Transport Chair is intended to transport patients within acute, alternative and long term care facilities. The device can be operated indoors on carpeting, linoleum and other floors, and on sidewalks. The BREEZ Electric Transport Chair is controlled, steered and operated completely by a trained caregiver.
    Device Description
    The BREEZ Electric Transport Chair is a motorized device that allows caregivers to move patients up to 750 pounds in weight. The device has self-contained batteries to provide power that can be recharged by an on-board battery charger that can be plugged into a 120/240 VAC outlet when the device is not in use. The device is supported by four wheels whereby the front wheels provide the motive force to propel the unit in either the forward or reverse direction. The caregiver directs the movement of the device using a steering handlebar and various hand-operated controls attached to the rear of the device.
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