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510(k) Data Aggregation
K Number
K230502Device 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/AWhy 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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