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510(k) Data Aggregation

    K Number
    K220290
    Device Name
    Revitalair 430+
    Manufacturer
    US Hyperbaric Network
    Date Cleared
    2023-05-04

    (457 days)

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

    US Hyperbaric Network

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Portable Hyperbaric Chamber Revitalair® 430+ is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at health institutions and physician offices.
    Device Description
    The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi rigid chamber for low pressures (operating at pressures of no greater than 1.5 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® 430+ consists of 2 parts, the cabin or chamber and the 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 of 1.5 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the Revitalair® 430+ has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside. The Revitalair® 430+ can be operated from the exterior. After folding it up, the Revitalair® 430+ is placed in its transportation box or in the optional carrying case.
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