Search Results
Found 3 results
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?
Product Code :
MJV
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.
Ask a Question
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?
Product Code :
MJV
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.
Ask a Question
K Number
K073401Device Name
EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
Manufacturer
MICROMEDICS, INC.
Date Cleared
2008-03-14
(101 days)
Product Code
MJV
Regulation Number
N/AWhy did this record match?
Product Code :
MJV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EarPopper 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 EarPopper 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 EarPopper is a non-surgical, non-drug related treatment for middle ear pressure problems such as:
- . Middle ear fluid (Otitis Media with Effusion)
- Eustachian Tube Dysfunction
- . Temporary hearing loss
- Ear pain and pressure caused by air travel .
- . Ear fullness caused by colds, allergies, sinusitis
Ask a Question
Page 1 of 1