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510(k) Data Aggregation

    K Number
    K971507
    Device Name
    O2 BOOT
    Manufacturer
    Date Cleared
    1997-11-07

    (196 days)

    Product Code
    Regulation Number
    878.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GWR MEDICAL, LLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the O2 Boot™ is to provide hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. Increasing the oxygen concentration above chronic open wounds with the use of this topical hyperbaric oxygen device, may promote the rate of healing and suppress bacterial growth. Indications for the O-Boot are 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitus ulcers 3) amputations/infected stumps 4) skin grafts 5) burns 6) frostbite.
    Device Description
    The GWR O2 Boot™ is a Topical Oxygen Chamber for Extremities. It is composed of a flexible plastic film shaped into a large boot. At the open end of the device there is a layer of white fabric impregnated with an acrylic adhesive and is used to secure the boot to the patient being treated. There are two tubes that pass through the film; one is to inject the O2 and the other contains a pressure relief valve that is set to maintain the proper pressure to inflate the boot, yet not over inflate the boot for treatment of the patient. In addition, plastic tubes are a part of the device and are used to transport the O2 from the O2 supply to the boot and create the oxygen chamber. The O2 Boot™ is designed to encapsulate the whole leg or arm and therefore treat multiple wounds that could be present on the leg in diabetic or geriatric patients. In addition, it is a single use, single patient, disposable device.
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