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510(k) Data Aggregation

    K Number
    K252268

    Validate with FDA (Live)

    Date Cleared
    2025-12-16

    (148 days)

    Product Code
    Regulation Number
    868.5440
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The V series Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis in a home, institutional, or travel environment. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

    Device Description

    The V series Portable Oxygen Concentrator is intended to release oxygen for respiratory therapy by means of molecular sieve/pressure swing adsorption technology. The machine utilizes the physical principle of pressure swing adsorption with a molecular sieve to adsorb nitrogen and other gas components Device to increase oxygen concentration. It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The V series devices are small, portable and may be used in home, institutional, or travel environment.

    The V series Portable Oxygen Concentrator has both pulse mode and continuous mode, there are 6 level/gear settings for pulse mode, and 1 level/gear setting for continuous mode, see the descriptions in the table below:

    Gear SettingsLevel 1 (Gear 1)Level 2 (Gear 2)Level 3 (Gear 3)Level 4 (Gear 4)Level 5 (Gear 5)Level 6 (Gear 6)Mode C
    Rated Flow Rate210 mL/min420 mL/min630 mL/min840 mL/min1000 mL/min1200 mL/min1.2 L/min

    The 4 models have the same appearances, intended use, technical characteristics, and working principle, only a difference in gear setting, that is, the 4 models differ in the firmware/software, see the description in table below:

    ModelsLevel 1Level 2Level 3Level 4Level 5Level 6Mode C
    V5//
    V5C/
    V6/
    V6C

    "●" means "standard configuration"; "/" means "do not have the configuration"

    AI/ML Overview

    N/A

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