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510(k) Data Aggregation

    K Number
    K053498
    Device Name
    HYPEROX 101
    Manufacturer
    Date Cleared
    2006-03-15

    (89 days)

    Product Code
    Regulation Number
    868.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    WJO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hyperbaric Oxygen Therapy (HBOT) is a painless procedure in which a person is exposed to increased pressure, thus allowing greater absorption of oxygen throughout body tissues. This increased pressure allows more oxygen to reach the cells within the body therefore contributing to the many healing and therapeutic benefits. The expressed and intended use of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber is to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class U prescriptive device, it is further intended for physician involvement in their procurement and routine use. The conditions listed as appropriate for the use of Hyperbaric Oxygen Treatment are: - Air or gas embolism - Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning - Clostridial myositis and myonecrosis - Crush injury, compartment syndrome and other acute traumatic ischemias - Decompression sickness - Enhanced healing of selected problem wounds - Exceptional blood loss anemia - Necrotizing soft tissue infections - Osteomyclitis (refractory) - Delayed radiation injury (soft tissue and bony necrosis) - Skin grafts and flaps (compromised) - Thermal burns - Intercranial abscess
    Device Description
    The HyperOx Hyperbaric Oxygen Treatmcnt Chamber is a Class A multi-place hyperbaric chamber designed to treat up to 10 patients up to 32 psig. The device will use compressed, dried/chilled air as the pressurization gas and 100% medical oxygen as the treatment gas. Specifications of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber are: Design Code: ASME Section VIII, Div 1 and ASME-PVHO- Operating Pressure: 32 psig Operating Temperature: 65 to 95 degrees F Design Pressure: 45 psig Design Temperature: 65 to 95 degrees F Design Life: 70,000 cycles (approx. 30 years) Hydrostatic Pressure: 42.0 psig Weight: 11,200 lbs. (5.6 tons) Dimensions: 72" W X 88" H X 16' 6" L Doorway Opening Size: 30" X 60" clear opening Lighting: Four (4) external dimmable lights (1) 12" dia. clear view portlight in door (8) 9" dia. clear view portlights in shell Capacity: Up to 11 occupants Fire Suppression: IAW NFPA 99 Finish: SSPC-SP-10 shotblast, primed & painted Controls: Manual electropneumatic pressurization Manual electropneumatic depressurization Ventilation: Constant airflow BIBBS with dump: Four Oxygen Flow Manifold: Twelve feeds to O2 mask Gas Analysis: Oxygen and carbon dioxide Communications: Wireless PA Entertainment (optional): Wireless internet connection External TV system w/remote & DVD player AM/FM tuner with CD player
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