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510(k) Data Aggregation

    K Number
    K240569
    Device Name
    FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
    Manufacturer
    Fink Engineering Pty Ltd
    Date Cleared
    2024-11-21

    (266 days)

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

    Fink Engineering Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The conditions listed as appropriate for the use of HBO recognized by the Undersea & Hyperbaric Medical Society's (UHMS) Hyperbaric Oxygen Therapy Committee Report, as follows: - 1. Air or gas embolism - 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning - 3. Clostridial myonecrosis and myonecrosis - 4. Crush injuries, compartment syndrome, and other acute traumatic ischemias - 5. Decompression sickness - 6. Enhancement of healing of selected problem wounds - 7. Exceptional blood loss anemia - 8. Necrotizing soft tissue infections - 9. Osteomyelitis (refractory) - 10. Delayed radiation injuries (soft tissue and bony necrosis) - 11. Compromised grafts and flaps - 12. Acute Thermal Burn Injury - 13. Intracranial abscess
    Device Description
    The FINK Hyperbaric Chamber is the rectangular pressure vessel that is identical in construction to the rectangular hyperbaric chambers covered by Fink's previously cleared K031649 which are all designed and built to meet the Safety Standard for Pressure Vessels for Human Occupancy ASME PVHO-1 and are certified accordingly. Chamber configurations vary depending upon the requirements set forth by the end user and supplied in the following configurations: - Single Compartment - FESL - Double Compartment - FEDL - Triple Compartment FETL ● Patient capacities can range from four (4) to 28 twenty-eight (28) patients per chamber depending on the number of compartments required by the User. The pressure range for the individual compartments may also vary for the same reason with a minimum of 3.0 ATA to 6.0 ATA maximum allowable working pressures and design temperature range from 15℃ to 38℃ per compartment. The specific parameters for each chamber are defined by a User Design Specification which is approved by a Registered Professional Engineer in accordance with ASME PVHO-1. These chambers also comply with the National Fire Protection Agency (NFPA) The chambers include the following features: - Fire Protection - Compressed air system ● - Oxygen Delivery ● - Environmental control system ● - Unintended power supply ● - Control Console ●
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    K Number
    K031649
    Device Name
    SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
    Manufacturer
    FINK ENGINEERING PTY LTD
    Date Cleared
    2003-12-05

    (191 days)

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

    FINK ENGINEERING PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is the expressed, intended use of the Fink Engineering SL8/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities 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 their 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 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 SL/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities are Class A multiplace hyperbaric chambers designed to treat up to 8 (SL/DL8) or 20 (TL20) patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig) for the SL8 and up to 6 Atmospheres Absolute (ATA) or 73.5 psig for the DL8 and TL20. Each facility utilizes air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas. The SL/DL8/TL20 rectangular hyperbaric chamber(s) include as a key component a new and very user-friendly rectangular chamber designed and manufactured specifically for the medical community to be used for hyperbaric oxygen treatment. The design of this unique ASME PVHO chamber has been driven by comments from hyperbaric physicians, technicians and nurses who require their equipment to be simple, easy to use and to simulate clinical conditions found elsewhere in their working environment. The SL/DL8/TL20 facilities place major emphasis on patient comfort and user-friendly operator controls and incorporate several innovative and unique features including: - A large, comfortable rectangular hyperbaric chamber that has been outfitted to appear like any other clinical room in a hospital to reduce patient anxiety - A rectangular medical lock with a unique locking system enabling single-handed operation - Large walk-trough rectangular sliding doors that fit flush with the floor so that patients can be wheeled into the chamber without bumping over a door jam - An easy to use control panel with large VDU display to monitor the treatment profile including the internal chamber pressure, temperature, humidity, oxygen and carbon dioxide parameters - An oxygen delivery system with venturi assisted overboard exhaust to eliminate the possibility of "shrink wrapping" patients with their oxygen hoods - Whisper quiet ventilation system to pneumatically control temperature, humidity and upper oxygen limit without the need for internal electrical blowers - Aesthetically pleasing external chamber cladding
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