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510(k) Data Aggregation
K Number
K052866Device Name
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
Manufacturer
Date Cleared
2005-12-13
(63 days)
Product Code
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
OXYHEAL HEALTH GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
It is the expressed, intended use of the Oxyheal 1000 Monoplace Hyperbaric Chamber series 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 II prescriptive device, it is further intended for physician involvement in the procurement and routine use.
The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee report (2003) 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 of healing in selected problem wounds
7. Exceptional blood loss (anemia)
8. Intracranial abscess
9. Necrotizing soft tissue infections
10. Osteomyelitis (refractory)
11. Delayed radiation injury (soft tissue and bony necrosis)
12. Skin Grafts and flaps (compromised)
13. Thermal burns
Device Description
The OxyHeal 1000 series is a Class B monoplace hyperbaric chamber system designed to treat 1 patient to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 30 pounds per square inch gauge (psig). The chamber uses compressed 100% oxygen as the pressurization gas as well as the hyperbaric treatment gas. The overall external length of the chamber is 105" inches. Its internal diameter is 33.5" inches. Pressurization and ventilation is continuously provided by compressed 100% oxygen. The patient breathes the chamber atmosphere directly. An air-break assembly using a regulated medical air source and mask is available. A low-voltage patient intercommunication system provides communications between the patient 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, manually operated control system is provided for double control redundancy. A series of penetrators are provided in the vessel end caps wall to allow user supplied intravenous lines, suction, medical monitoring leads, etc., to be used as required.
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