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510(k) Data Aggregation
K Number
K081506Device Name
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
Manufacturer
HYPERBARIC AMERICA, LLC
Date Cleared
2008-07-25
(57 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
HYPERBARIC AMERICA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is the expressed, intended use of the Hyperbaric America, LLC, Presidential Hyperbaric Chamber Systems 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 its procurement and routine use.
The conditions listed as appropriate for the use of HBO by the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003) are as follows:
- 1. Air or gas embolism
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide 2. poisoning
- Clostridial myositis and myonecrosis
- 4. Crush injury, compartment syndrome, and other acute traumatic ischemias
- Decompression sickness
- Enhanced healing of selected problem wounds 6.
- 7. Exceptional blood loss anemia
- Necrotizing soft tissue infections 8.
- 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 Hyperbaric America Presidential Monoplace Hyperbaric Chamber Systems (Model HA-34 and HA-38) are Class B monoplace hyperbaric chambers designed to treat one patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29,4 pounds per square inch gauge (psig). The chamber uses 100% oxygen as the pressurization gas and patient breathes the oxygen contained inside the chamber as the hyperbaric treatment gas. Air pressurization with oxygen delivery by mask is optional
The Presidential Hyperbaric Oxygen Systems are designed and fabricated in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, Pressure Vessels; ANSI/ASME-PVHO-1 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy, 2007 Edition); and, NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities, 2005 Edition. The overall external length of both models is 92 inches. The internal diameter of Model HA-34 is 33.5 inches and of Model HA-38 is 38 inches. The chamber is constructed by half-steel and half-acrylic tube. A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 20 and provides communications between the patients in the chamber and the outside chamber operator.
The system consists of an operator control panel that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. Spare penetrators are provided to allow user supplied medical monitoring leads, etc., to be used as required. Patient is loaded and unloaded by a retractable qurney. When loading, patient lies down on the fire retardant foamed bunk, aligned to the rails of the chamber and fixes four wheels of the gurney, then push the bunk into the chamber. Unloading the patient with an opposite procedure. The chamber is also equipped with for pressurization. There is no gas supply for pressurization before the chamber's door is closed and secured thoroughly.
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