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510(k) Data Aggregation
K Number
K952545Device Name
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
Manufacturer
Date Cleared
1997-05-28
(726 days)
Product Code
Regulation Number
868.5470Why 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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