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510(k) Data Aggregation

    K Number
    K244035
    Date Cleared
    2025-09-19

    (263 days)

    Product Code
    Regulation Number
    868.5630
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The portable mesh nebulizer is intended to aerosolize medicine liquid for inhalation by the patient. The device is used with adult and pediatric (≥3 years old) both in hospital, home, and sub-acute settings.

    It is not intended for use with Pentamidine.

    Device Description

    JM821 portable mesh nebulizer is a portable vibrating mesh nebulizer, which incorporates a piezoelectric transducer that vibrates at a nominal frequency when electrical current is applied. It is designed to nebulize liquid medications into fine particulates for inhalation by a patient, so as to therapy respiratory diseases.

    The subject device is portable size, handheld design, it is powered by a 3.7V d.c. internally lithium battery, which is charged by an adapter.

    The subject device does not contain any medicine. Only use physician-prescribed solutions that are approved for use with a general-purpose nebulizer. Consult drug manufacturer's instructions regarding suitability for nebulization.

    The portable mesh nebulizer is single-patient, multiple-use. The mask can be can used for 30 sessions of aerosol treatment.

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