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510(k) Data Aggregation

    K Number
    K241338
    Device Name
    Peak Flow Meter
    Manufacturer
    Chongqing Moffy Innovation Technology Co.,Ltd.
    Date Cleared
    2024-12-31

    (232 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chongqing Moffy Innovation Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SMPF-1A, SMPF-1B, SMPF-2A, SMPF-2B, SMPF-3A, SMPF-3B: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory onditions such as asthma. The device is for Over-The-Counter Use. SMPF-1C, SMPF-1D, SMPF-2C, SMPF-2D, SMPF-3C, SMPF-3D: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume (FEVI) in one second at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.
    Device Description
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    K Number
    K240959
    Device Name
    Respiratory Muscle Trainer
    Manufacturer
    Chongqing Moffy Innovation Technology Co.,Ltd.
    Date Cleared
    2024-12-18

    (254 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chongqing Moffy Innovation Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Respiratory Muscle Trainer is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways. Respiratory Muscle Trainer vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways. The device may also be useful in the removal of mucus from patients who have chronic bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.
    Device Description
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