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510(k) Data Aggregation
K Number
K203754Device Name
Eustachi Ear Pressure Relief Device
Manufacturer
Exercore, LLC
Date Cleared
2021-02-19
(58 days)
Product Code
MJV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Exercore, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eustachi is indicated for the treatment of negative middle ear pressure.
Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Eustachi provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
Device Description
The Eustachi device is a battery-operated device 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 Eustachi device is activated by pressing and holding the power 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.
Eustachi is provided non-sterile, and is designed for reuse with a single patient.
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