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510(k) Data Aggregation
K Number
K181219Device Name
OptiPillows EPAP Mask
Manufacturer
Cpapnea Medical Supply
Date Cleared
2018-08-03
(88 days)
Product Code
LWF
Regulation Number
874.3900Why did this record match?
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Matched: '874.3900'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OptiPillows EPAP Mask is intended for use during sleep to alleviate snoring. It is intended for the adult population with snoring only.
Device Description
OptiPillows EPAP mask is a nasal dilator device for alleviation of snoring. The EPAP mask is a reusable device. The EPAP mask has nasal pillows that fit against the nostrils similar to the ones used in several nasal pillow CPAP masks. The EPAP mask has a one-way valve attached to it that allows air to flow freely without resistance during inspiration. The mask is held in place with adjustable head straps connected to the sides of the mask. During expiration, the air is redirected through a narrow opening, on the side of the expiratory opening creates resistance to airflow, thus increasing the back pressure in the nose, mouth, and upper airways. The increase in back pressure during expiration prevents the collapse of the upper airways, alleviating airway obstruction. The level of back pressure can be adjusted to the patient comfort by turning a rotating sleeve/collar to open or close the expiratory opening on the side of the valve. The adjustable expiratory resistance improves the comfort and safety for the user and facilitates adaptation to the EPAP mask.
The EPAP mask is a small device and is used like a CPAP mask, but does not require using a power supply, a CPAP machine or tubing that restricts movement of the patient during sleep.
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K Number
K120665Device Name
INVENT SNORING DEVICE
Manufacturer
VENTUS MEDICAL, INC.
Date Cleared
2012-06-12
(99 days)
Product Code
LWF
Regulation Number
874.3900Why did this record match?
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Matched: '874.3900'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InVent Snoring Device is intended to reduce or eliminate snoring.
Device Description
As with the predicate device, the subject device is a nasal dilator intended to reduce or eliminate snoring. While the predicate device is an internal nasal dilator, the subject device is an external nasal dilator in which the device is placed over the patient's nostrils. As with the predicate device, the subject device creates dilating pressure or expiratory positive airway pressure (EPAP) to dilate and open the nasal airway. The device directs expiratory flow though selected pathways, which maintain nasal airway pressure and help maintain nasal passage dilation.
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K Number
K040491Device Name
CHIN-UP STRIP
Manufacturer
DALE MILLER, INC. - THE CHIN-UP COMPANY
Date Cleared
2004-09-10
(197 days)
Product Code
LWF
Regulation Number
874.3900Why did this record match?
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Matched: '874.3900'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chin-Up Strip promotes and enhances nasal breathing to help Breathe Right nasal strips to reduce or eliminate snoring.
The Chin-Up Strip supports the chin (mandible) during sleep, thereby promoting and reducing mouth breathing and oral venting.
Device Description
Not Found
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