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510(k) Data Aggregation

    K Number
    K051759
    Device Name
    FLEXI-LITE, MODEL FL-V1.2
    Manufacturer
    PERFORMANCE HYPERBARICS
    Date Cleared
    2005-11-17

    (141 days)

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

    PERFORMANCE HYPERBARICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide mild hyperbaria for the treatment of Acute Mountain Sickness (AMS) and its associated mild symptoms. The Flexi-Lite Hyperbaric chamber is a rugged & portable hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician.
    Device Description
    The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 5 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523 "oiless, breathable air compressor" to pressurize the chapplice und provide a suitable environment for the occupant. The Flexi-Lite construction utilizes and bag design with the inner bag containing the pressure and an exterior hag to provide structural support. All components are attached to the inner bag utilizing oulkhead connections. It is outfitted with two externally mounted metal relief valves (set out nedit two metal Air addition valves (one external & one internal), two metal depressurization valves (one external & one internal), two pressure gauges (one external & one internal, and one metal Air sampling port. In total it weighs 39 lbs (compressor adds another 54 lbs).
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