Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K132205
    Device Name
    ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
    Manufacturer
    Date Cleared
    2014-06-06

    (325 days)

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

    INOVA LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Actives DUO2 Oxygen Concentrator System is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home or institutional/hospital setting.
    Device Description
    The Activox DUO2 Oxygen Concentrator is designed to be primarily a stationary device for home/institutional use. The LifeChoice Activox POC is a portable device that provides additional functionality of the Activox DUO2Oxygen Concentrator System. The Activox DUO2 Oxygen Concentrator base unit must be connected to the LifeChoice Activox POC a minimum of once every 45 days in order for the base unit to function as intent of this feature is to ensure the user at least periodically charges the battery powered LifeChoice Activox POC. While the Activox DUO2 is connected, it will charge the internal battery for the LifeChoice Activox POC. The Activox DUO2 can also charge the external battery (sold separately) for the LifeChoice Activox POC after the internal battery is charged.
    Ask a Question

    Ask a specific question about this device

    K Number
    K113317
    Device Name
    LIFECHOICE OXYGEN CONCENTRATOR
    Manufacturer
    Date Cleared
    2011-12-28

    (48 days)

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

    INOVA LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.
    Device Description
    The LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life supporting. The device provides approximately 90% oxygen to patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 5.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which can be used in a home, institution or travel environment. The device uses molecular sieve pressure swing adsorption technology.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1