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510(k) Data Aggregation

    K Number
    K971964
    Device Name
    OXLIFE EXCELL OXYGEN CONCENTRATORS
    Manufacturer
    OXLIFE, INC.
    Date Cleared
    1997-08-15

    (79 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    OXLIFE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OxLife Oxygen Concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities. The OxLife Oxygen Concentrators are indicated for the administration of supplemental oxygen.
    Device Description
    The OxLife Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home, automobile or institution without a continuous source of purfied oxygen. They are not life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to suck room air through a pre-filter and HEPA filter into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a 'T' fitting that directs most of the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen. The major change to the device has been the reduction in the size of the molecular sieve tanks and subsequent volume of sieve material. This change allowed the elimination of the crossover valve and required a reduction of the cycle time. A separate change to be implemented is the addition of an optional, larger inverter capable of operating the 6 LPM models using 12 Volt DC power. Currently, these models are specifically excluded from 12 volt use due to their large power draw.
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    K Number
    K955549
    Device Name
    OXLIFE OXYGEN CONCENTRATORS
    Manufacturer
    OXLIFE, INC.
    Date Cleared
    1996-03-15

    (101 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    OXLIFE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OxLife oxygen concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Device Description
    The OxLife Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not life-supporting or life-sustaining devices. The device works by filtering room air into a holding tank. The air is then flushed through two aluminum welded molecular sieve tanks in series. The molecular sieve material absorbs nitrogen which comprises approximately 78% of the makeup of the room air. The resulting gas is approximately 93% oxygen. This modification is designed to increase the output of the device to enable an oxygen flow of uc to 6 LPM at 93% ± 3% purity. The device will be marketed with several options to provide the most marketing flexibility. One set of devices will be marketed with a single oxygen outlet through a single flow meter. The others will be marketed with two oxygen outlets, each with it's own regulator and flow meter. The single outlet devices will be sold with a 5 LPM (L-5) model or 6 LPM (L-6) model with a 5 LPM or 6 LPM flow meter respectively. The dual outlet device (DL-3) will be marketed with two 6 LPM flow meters. This device is designed to provide for the needs of two patients in any combination of flows up to 6 LPM. The major change to the device has been the replacement of the single-headed Thomas WOB-L compressor with a dual-headed Thomas WOB-L compressor. This doubled the output to 3 CFM, facilitating the increased oxygen flow.
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