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510(k) Data Aggregation

    K Number
    K981938
    Device Name
    TAMPA HYPERBARIC MONOPLACE CHAMBER
    Manufacturer
    TAMPA HYPERBARIC ENT.
    Date Cleared
    1999-07-06

    (399 days)

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

    TAMPA HYPERBARIC ENT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended use of our device is to correct tissue hypoxia for treatment of: *Air or gas embolisms *Decompression sickness Carbon monoxide poisoning with or without cyanide complications Smoke inhalation Exceptional blood loss or anemia Clostridial myonecrosis (gangrene) Selected problem chronic wounds Crush injury, compartment syndrome and acute traumatic ischemias Compromised skin grafts Osteomyelitis Thermal burns Osteoradionecrosis (radiation burns) Necrotizing soft tissue infections *In gas embolism and decompression sickness hyperbaric oxygenation van be used as a primary therapy. In the other indications hyperbaric oxygenation is an adjunctive treatment to further primary medical intervention.
    Device Description
    Tampa Hyperbaric Monoplace Chamber Stainless steel; supine patient position on gurney; eight acrylic viewports on 36" diameter chamber. All interior materials cleaned for oxygen service. Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy.
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    K Number
    K960389
    Device Name
    HYPERBARIC CHAMBER
    Manufacturer
    TAMPA HYPERBARIC ENT.
    Date Cleared
    1996-12-05

    (318 days)

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

    TAMPA HYPERBARIC ENT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Decompression sickness; Carbon monoxide with or without cyanide poisoning; Smoke inhalation; Exceptional blood loss; Clostridial myonecrosis; Crush injury, compartment syndrome and acute traumatic ischemias; Selected Problem Wounds; Compromised skin grafts; Osteomyelitis; Osteoradionecrosis; Thermal burns; Necrotizing soft tissue infections.
    Device Description
    This hyperbaric chamber is generally safe and effective when used within documented parameters relative to decompression table times for repeitive use. The intake and exhaust valves are sized (½") to slow the time required for full compression and decompression. This provides a fail-safe method for filling the chamber with air and alternately releasing the air prior to egress. It requires 15 minutes to fill the chamber to the optimum working pressure (15 psig) and 8 minutes to depressurize the chamber. While this is slower than most chambers already on the market the longer time is actually more comfortable for the patients. Incidental temporary side-effects (i.e. eardrum pain or damage and psychological anxicty) arc rare if contraindications are screened and the attendant monitors the occupant. While some more serious side-effects (i.e. collapsed lung and oxygen toxicity) were documented in other similar hyperharic chambers, those problems were evoked at greater pressures with the increased risk of those type medical misadventures. On the other hand, this device has the relief valve designed to limit pressure to 21 psig. This added feature effectively limits risk and assures overall safety to hyperbaric chambers already in commercial use. The chamber uses an in-swinging steel hatch door with a rubber "O" ring in the contacting face. There is no latch or other device to lock. A reasonable push against the hatch while the air pressure rises will initiate hatch closure. Air pressure holds the hatch securely closed. There are no high voltage devices placed inside this hyperbaric chamber. There are no new technological materials used. There are manual air pressure valves to prevent inadvertent or unauthorized changes. There are no exposed sharp edges in tank construction. The construction is mechanically stable and has no exposed moving parts. The hyperbaric chamber is secure from vibration and offers 3/8 inch thick steel protection to the occupants in the unlikely event of an outside catastrophe. The occupants have an internal emergency release valve for additional security. The tank construction is coated to withstand fluid spills. The chamber is certified to operate within specifications up to 150° F and has been hydrostatically tested to assure performance. The surface temperature of the chamber does not increase during its operation. The air is certified pure breathing quality. There are no wires in the device that could risk strangulation. This device is intended to have operator assistance to monitor the activity inside and outside the hyperbaric chamber . There are four small chairs bolted inside the chamber along a certified welded angle iron. This allows patients to sit during the hyperbaric sessions. There is adequate room for these four chairs to be removed and replaced with two cots bolted along the same angle iron without welding any new metal to the chamber (new welds would void certification). There are two certified viewports for visual inspection of the occupants.
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