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510(k) Data Aggregation

    K Number
    K240328
    Device Name
    eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
    Date Cleared
    2024-05-16

    (101 days)

    Product Code
    Regulation Number
    872.5575
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    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
    K223446
    Device Name
    eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
    Date Cleared
    2023-01-18

    (64 days)

    Product Code
    Regulation Number
    872.5575
    Why did this record match?
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    Matched: '872.5575'

    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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    K Number
    DEN200018
    Device Name
    eXciteOSA with remote and eXciteOSA without remote
    Date Cleared
    2021-02-05

    (318 days)

    Product Code
    Regulation Number
    872.5575
    Why did this record match?
    Search-Everything :

    Matched: '872.5575'

    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 snoring and mild obstructive sleep apnea (AHI<15) for patients that are 18 years or older.
    Device Description
    The eXciteOSA device is an external tongue muscle stimulator that delivers neuromuscular electrical stimulation to intrinsic and extrinsic tongue muscles in the daytime in order to increase muscle tone and prevent excess tongue muscle relaxation during sleep. The device is indicated to reduce snoring and mild obstructive sleep apnea in adults 18 years and older. The device is placed in the mouth, with electrodes located above and 10 10 electrodes located below the tongue. The therapy consists of a series of pulse bursts with rest periods and is used for 20 minutes during wakeful state for a period of 6-weeks. The electrical stimulation is directed at the tongue and in particular at a group of muscles comprising the genioglossus muscle, the biggest muscle in the oral cavity. The device is intended to use the established technology of neuromuscular electrical stimulation (NMES) for the muscles of the oral cavity as a training tool in awake individuals to improve the tone of their throat muscles and reduce the problem of snoring and mild OSA during sleep. The eXciteOSA is a system made out of different components and sold in different configurations. The device consists of three components: 1) Washable Flexible Electrode Mouthpiece with electrode array that fits onto the tongue. 2) Rechargeable Control Unit that attaches to the mouthpiece via a USB-C connection. 3) Remote Control Unit and/or Smartphone App that manages the functions of the device.
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