Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K101262
    Device Name
    FLEXI-LITE
    Manufacturer
    PRESSURE-TECH, INC.
    Date Cleared
    2010-06-10

    (36 days)

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

    PRESSURE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexi-Lite Hyperbaric chamber is a 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. Caution: Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 4 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523/1023 "oil-less, breathable air compressor" to pressurize the chamber and provide a suitable environment for the occupant. The Flexi-Lite construction utilizes a dual bag design with the inner the ooonpining the pressure and an exterior bag to provide structural support. All components are attached to the inner bag utilizing bulkhead connections. It is outfitted with two externally mounted metal relief valves (set at 4 psi), 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).
    Ask a Question

    Page 1 of 1