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510(k) Data Aggregation
K Number
K240328Device Name
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Manufacturer
Date Cleared
2024-05-16
(101 days)
Product Code
Regulation Number
872.5575Why did this record match?
Applicant Name (Manufacturer) :
Signifier Medical Technologies Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older.
Device Description
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older. The small electric currents delivered through the mouthpiece stimulate the tongue and improve its muscle function. The improved function of the tongue muscle will help in keeping the upper airway open during sleep and reduce the vibration of the throat region.
Two tabs of the mouthpiece sit comfortably above and below the tongue. The mouthpiece is designed such that when the mouth is gently closed, it will naturally sit around the tongue and won't move during the therapy session. The device can be used at any point during the day.
The device can be controlled by a smartphone application. This app can be downloaded from the App store (Apple iOS) or Play Store (Google Android). The mobile app software can be used on iPhone 11 Pro & iPhone 11 Pro Max and above, with iOS 15.0 and higher. The mobile app software can also be used with Bluetooth support and Android 10.0 and above. eXciteOSA® uses Bluetooth Smart; mobile devices used must be compatible with Bluetooth Smart.
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K Number
K223446Device Name
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Manufacturer
Date Cleared
2023-01-18
(64 days)
Product Code
Regulation Number
872.5575Why did this record match?
Applicant Name (Manufacturer) :
Signifier Medical Technologies Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older.
Device Description
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older. The small electric currents delivered through the mouthpiece stimulate the tongue and improved function. The improved function of the tongue muscle will help in keeping the upper airway open during sleep and reduce the vibration of the throat region. Two tabs of the mouthpiece sit comfortably above and below the tongue. The mouthpiece is designed such that when the mouth is gently closed, it will naturally sit around the tongue and won't move during the therapy session. The device can be used at any point during the day. The device can be controlled by a smartphone application. This app can be downloaded from the App store (Apple iOS) or Play Store (Google Android). The mobile app software can be used on iPhone 6/6 Plus, iPhone 6/6s Plus, iPhone 7/7 Plus, iPhone 8/8 Plus, iPhone X, with iOS 11.0 and higher. The mobile app software can also be used with Android devices with BLE support (Bluetooth 4.0) and Android 7.0 and above. eXciteOSA® uses Bluetooth Smart; mobile devices used must be compatible with Bluetooth Smart.
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