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510(k) Data Aggregation

    K Number
    K230502
    Device Name
    Ear Pressure Relief Device(Model:ER813B)
    Manufacturer
    Ningbo Albert Novosino Co., Ltd.
    Date Cleared
    2023-06-09

    (105 days)

    Product Code
    MJV
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Albert Novosino Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ear Pressure Relief Device is indicated for the treative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing loss. The Ear Pressure Reliever provides a method of ventilating the middle ear by momentarily increasing the air pressure in the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
    Device Description
    The Ear Pressure Relief Device is designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes. For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Ear Pressure Relief Device is activated by pressing and holding the adjustment button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear. Ear Pressure Relief Device is provided non-sterile, and is designed for reuse with a single patient.
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