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510(k) Data Aggregation
K Number
K132003Device Name
WINX SLEEP THERAPY SYSTEM
Manufacturer
Date Cleared
2014-06-13
(347 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
APNICURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Device Description
The Winx Sleep Therapy System consists of four (4) main components and two (2) sizing methods. The components are: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application). The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
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K Number
K130538Device Name
WINX SLEEP THERAPY SYSTEM
Manufacturer
Date Cleared
2013-05-22
(82 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
APNICURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Device Description
The Winx Sleep Therapy System consists of four (4) main components and two (2) sizing methods. The components are: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application). The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
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K Number
K122130Device Name
WINX SLEEP THERAPY SYSTEM
Manufacturer
Date Cleared
2012-10-31
(105 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
APNICURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Device Description
The Winx Sleep Therapy System consists of four (4) main components: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
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K Number
K111549Device Name
ATTUNE SLEEP APNEA SYSTEM
Manufacturer
Date Cleared
2012-03-30
(301 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
APNICURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Attune Sleep Apnea System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Device Description
The Attune Sleep Apnea System consists of three (3) main components: a small electronic bedside console, a soft polymer mouthpiece, and a flexible polymer tube that connects the mouthpiece to the console. A mouthpiece holder is provided for mouthpiece storage and use during weekly system cleaning.
The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
Console: The console generates a gentle negative pressure, collects excess saliva, records patient use time, and monitors pressure. The console is provided with a power cord, which connects to a standard electrical outlet. An optional laboratory console is available for use in a sleep laboratory. The laboratory console includes wires that extend from the console. The wires connect to the sleep laboratory's polysomnography (PSG) system, allowing the sleep technicians to view the console's pressure on the same monitor as the other PSG channels.
Mouthpiece: The mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite wax to obtain an impression of each patient's teeth and a sizing template to determine the best mouthpiece size.
Tubing: The tubing connects to the console by screwing into the console base and to the mouthpiece with luer connectors.
Use: The patient connects the system and places the mouthpiece in his or her mouth. The mouthpiece is worn during sleep. The console generates a gentle, negative pressure, which is delivered through the mouthpiece into the oral cavity and holds the tongue and soft palate out of the airway.
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