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510(k) Data Aggregation

    K Number
    K171899
    Device Name
    Revitalair 430F
    Manufacturer
    Oxavita S.R.L.
    Date Cleared
    2019-11-22

    (879 days)

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

    Oxavita S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Portable Hyperbaric Chamber Revitalair® 430F is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at physician offices and health institutions.
    Device Description
    The Portable Hyperbaric Chamber Revitalair® 430F is a hyperbaric chamber for low pressures (operating at pressures of no greater than 1.4 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012). Revitalair® 430F consists of 2 parts, the cabin or chamber and the compression system or compressor's cabinet. The chamber, weighing 62 pounds, is constructed of an airtight polyester-based plastic fabric joined by aluminum rings, forming a cylinder 900 mm in diameter and 1850 mm in length (Figure 1). The chamber is inflated with atmospheric air through an electric compressor. Fittings allow the chamber to be connected to compressed air by means of manually controlled valves. The safety or relief valves are operated at pressures above 1.3 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the chamber. The Revitalair® 430F has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside. The Revitalair® 430F can be operated from the interior as well as from the exterior. After folding it up, the Revitalair® 430F is placed in its transportation box or in the optional carrying case.
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