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510(k) Data Aggregation

    K Number
    K252616

    Validate with FDA (Live)

    Device Name
    Portable oxygen concentrator (JLO-190P)
    Manufacturer
    Shenzhen Homed Medical Device Co., Ltd.
    Date Cleared
    2025-12-22

    (125 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    18 - 150
    Reference & Predicate Devices
    K250671,K230052
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Portable Oxygen Concentrator(JLO-19P) provides a high concentration of oxygen to patients requiring supplemental oxygen. It may be used in home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

    Device Description

    The Portable Oxygen Concentrator JLO-190P is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.

    This product adopts the induction pulse mode to deliver oxygen. The induction pulse mode relies on the sensitive probe inside the machine to detect your breathing and deliver oxygen according to your breathing frequency. It monitors your breathing rate and delivers oxygen when you breathe in and stops when you breathe out.

    Portable oxygen concentrator consists of air compressor, molecular sieve adsorption tower, oxygen storage tank, control system, alarm system, accessories (nasal oxygen cannula, lithium battery pack).

    AI/ML Overview

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