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510(k) Data Aggregation

    K Number
    K030418
    Device Name
    MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
    Date Cleared
    2004-01-29

    (353 days)

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

    MAKAI MARINE INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The conditions listed as appropriate for the use of (HBO) in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows: 1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning 3. Clostridial myositis and Myonecrosis (Gas Gangrene) 4. Crush injury, compartment syndrome, and other acute traumatic Ischemias 5. Decompression sickness 6. Enhanced healing of selected problem wounds 7. Exceptional blood loss anemia 8. Necrotizing soft tissue infections 9. Osteomyelitis (refractory) 10. Delayed radiation injury (soft tissue and bony necrosis) 11. Skin grafts and flaps (compromised) 12. Thermal burns 13. Intracranial abscess
    Device Description
    The Makai Marine Industries Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber system designed to treat up to 20 patients to a maximum treatment pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch gauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas. The overall external length of the chamber can range from 11 feet to 40 feet. Its internal diameter can range from 42 inches to 180 inches. Large circular windows create a more open atmosphere and help reduce patient claustrophobia. Pressurization is provided by compressed air with 100% oxygen, administered to the patient by using properly fitting oral-nasal masks or head tents. A low-voltage patient intercommunication system provides communications between the patients in the chamber and the outside chamber operator. Single operator chamber pressure control is achieved via simple adjustable control valves providing infinite control. Multiple penetrators and/or penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. Where applicable a large rectangular door(s) allows a normal size patient gurney or wheelchair to be used to transport nonambulatory patients without having to transfer the patient to a smaller transport device.
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