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510(k) Data Aggregation

    K Number
    K952545
    Device Name
    WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
    Manufacturer
    Date Cleared
    1997-05-28

    (726 days)

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

    WRIGHT INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The following are approved indications: - l: Air or gas embolism. - 2: Carbon monoxide poisoning and smoke inhalation. Carbon monoxide complicated by cyanide poisoning. - 3: Clostridial myonecrosis (Gas gangrene). - 4: Crush injury, Compartment syndrome, and other acute traumatic ischemias . - 5: Decompression sickness. - 6: Enhancement of healing in selected problem wounds. - 7: Exceptional blood loss (Anemia) - 8: Necrotizing soft tissue infections (Subcutaneous tissue, Muscle, Fascia). - 9: Osteomyelitis (Refractory). - 10: Radiation tissue damage (Osteoradionecrosis). - ll. Skin grafts and flaps (Compromised). - 12. Thermal burns. - 13. Adjunctive hyperbaric oxygen in intracranial abscess.
    Device Description
    The Wright 1000 Mono Hyperbaric Camber: *Max operational pressure 30 PSIG. *Constructed out of SA516-70N steel *The 4 Large 14" Windows Constructed out of PVO Acrylic *Hydrostatic tested at 45 PSIG. *Welds are X-rayed *Welds magna Flux tested after hydrostatic test. *Manufactured by a ASME approved house and certified by ASME. Certification No. 28,352 *Manufactured under PVHO guidelines *Manufactured under NFPA Guidelines *Registered with National Board Of Pressure Vessel Inspectors. *Wiring to National Electrical code. *Electrical Testing: Electromagnetic and Safety testing Conducted. *Spacious interior *2 Way Communications *Pressure and Oxygen monitoring With alarms. *Programmable Treatment Pressure Alarms *Variable ventilation *Comfortable reclining chair
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