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510(k) Data Aggregation

    K Number
    K122560
    Device Name
    VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
    Manufacturer
    PAN-AMERICA HYPERBARICS, INC.
    Date Cleared
    2013-03-26

    (216 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAN-AMERICA HYPERBARICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VersalVent Model V1 Hyperbaric Chamber Ventilator is intended and indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.
    Device Description
    The VersalVent Model V1 Hyperbaric Chamber Ventilator provides ventilatory support for pediatric and adult patients who require mechanical ventilator support while undergoing hyperbaric chamber therapy under the direction of a physician. The Device is completely pneumatically operated by pressurized oxygen sources from the hospital main oxygen source or by oxygen cylinders. The Device provides controlled ventilation and imv ventilatory modes with operator-set inspiratory pressure relief capabilities as further described in Technical Characteristics on page S2.
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    K Number
    K021689
    Device Name
    PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
    Manufacturer
    PAN-AMERICA HYPERBARICS, INC.
    Date Cleared
    2002-10-24

    (154 days)

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

    PAN-AMERICA HYPERBARICS, 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 PAH-M10+2 Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber designed to treat up to 12 patients at up to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch qauge (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 is 7025mm (approx. 23 ft). Its internal diameter is 2500mm (approx. 8.2 ft). There are two compartments: main compartment and transfer compartment. Ten (10) seats and two (2) seats are installed in main compartment and transfer compartment respectively. Besides, there is one (1) additional seat installed in the main compartment for attendant. Two independent fire suppression systems, water deluge system and handline system, are installed in accordance with the requirement of NFPA 99, Chapter 19 (Chapter 20, 2002 Edition). Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oronasal masks or head tents. A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 19 (Chapter 20, 2002 Edition) and provides communications between the patients in the chamber and the outside chamber operator. It also provides patients with audio program content from external sources such as CD players, radios, etc. A Teledyne TED-191 oxygen analyzer is installed to monitor the concentration of oxygen inside the chamber continually. The system consists of an operator control console that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. A penetrator plate is provided in the vessel wall to allow user supplied medical monitoring leads, etc., to be used as required. The rectanqular door allows a normal size patient gurney to be used to transport nonambulatory patients into the chamber. This feature greatly improves patient handling safety.
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    K Number
    K021690
    Device Name
    PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
    Manufacturer
    PAN-AMERICA HYPERBARICS, INC.
    Date Cleared
    2002-10-24

    (155 days)

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

    PAN-AMERICA HYPERBARICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAH-M3+1 Hyperbaric Chamber System is intended to be procured and used by physicians to treat a variety of medical conditions that respond to hyperbaric oxygen. The Undersea & Hyperbaric Medical Society (UHMS) produces a list of medical conditions that have been identified for the appropriate primary or adjunctive use of hyperbaric oxygen. These approved conditions include: air or gas embolism; carbon monoxide poisoning and smoke inhalation; clostridial myonecrosis (gas gangrene); crush injury, compartment syndrome and other acute traumatic ischemias; decompression sickness; enhanced healing of selected problem wounds: exceptional blood loss anemia: necrotizing soft tissue infections: osteomyelitis (refractory); radiation tissue damage (osteoradionecrosis); compromised skin flaps and grafts; thermal burns; and, intracranial abscess. Aggressive research into the beneficial effects of hyperbaric oxygen, when appropriately applied, will result in additional medical conditions being added to the list of indications by the UHMS. It is the expressed, intended use of the Pan-America Hyperbarics' PAH-M3+1 Hyperbaric Chamber System 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 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 PAH-M3+1 Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber designed to treat up to 4 patients at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas. The PAH-M3+1 Hyperbaric Chamber System is 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); and, NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities (Chapter 20, 2002 Edition). The overall external length of the chamber is 4500mm (approx. 14.76 ft). Its internal diameter is 1016mm (approx. 40 inches). There are two compartments: main compartment and transfer compartment. Three (3) removable seats and one fixed (1) seat are installed in main compartment and transfer compartment respectively. Two independent fire suppression systems, water deluge system and handline system, are installed in accordance with the requirements of NFPA 99, Chapter 19 (Chapter 20, 2002 Edition). Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oronasal masks or head tents. A lowvoltage patient intercommunication system designed and installed in accordance with NFPA 99. Chapter 19 (Chapter 20, 2002 Edition) and provides communications between the patients in the chamber and the outside chamber operator. A Teledyne TED-191 oxygen analyzer is installed to monitor the concentration of oxygen inside the chamber continually. The system consists of an operator control console that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. A penetrator plate is provided in the vessel wall to allow user supplied medical monitoring leads, etc., to be used as required. The patients are loaded and unloaded by a retractable gurney, which is equipped with a sliding transport chair. When supine position is needed, a sliding bunk will be used instead. The chamber is also equipped with safety switch for pressurization. There is no gas supply before the chamber's door is closed and secured thoroughly.
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    K Number
    K021693
    Device Name
    PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
    Manufacturer
    PAN-AMERICA HYPERBARICS, INC.
    Date Cleared
    2002-10-24

    (155 days)

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

    PAN-AMERICA HYPERBARICS, 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 PAH-S1 Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber 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 das. The overall external length of the chamber is 2200mm (approx, 7.22 ft). Its internal diameter is 813mm (approx. 32 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 19 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 qurnev. 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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