Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K011866
    Device Name
    OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
    Manufacturer
    HYPERBARIC TECHNOLOGIES, INC.
    Date Cleared
    2002-06-06

    (357 days)

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

    HYPERBARIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 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 OxyHeal 2000 series is a Class A multiplace hyperbaric chamber system designed to treat up to 12 patients to a maximum operating 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 12 feet to 20 feet. Its internal diameter can range from 72 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 oro-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 a simple industrial adjustable controller with output and input feedback. A pneumatic and manually operated control system is provided for triple control redundancy. A penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. The large rectangular door 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.
    Ask a Question
    K Number
    K001409
    Device Name
    GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
    Manufacturer
    HYPERBARIC TECHNOLOGIES, INC.
    Date Cleared
    2000-08-02

    (90 days)

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

    HYPERBARIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1