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510(k) Data Aggregation

    K Number
    K190353
    Device Name
    Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
    Manufacturer
    Residential Home Sleep Services
    Date Cleared
    2020-04-10

    (420 days)

    Product Code
    PLC, LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Residential Home Sleep Services

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BFit Intraoral Appliances are likely to reduce snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older. Optionally, the DentiTrac Micro-Recorder may be incorporated into the Bfit device. The DentiTrac is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac System.
    Device Description
    The Bfit Intraoral Appliances are mandibular advancement devices which function by holding the jaw in a forward position during sleep (the principle of operation). The forward placement moves the tongue and pharyngeal tissue into a position to maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA) - the intended effect. The Bfit Sleep and Bfit Engage use mild elastic pull during the different stages of sleep where muscle activity is lost. In addition, both models of the oral appliance may be provided to the patient with an embedded DentiTrac micro-recorder used to capture the patient's compliance to the prescribed oral appliance therapy. Each oral appliance is custom-fit to the patient. The Bfit is available in four possible configurations which differ only in connecting mechanism and whether a DentiTrac is installed: Bfit Sleep (elastics), Bfit Sleep with DentiTrac, Bfit Engage (tension springs), and Bfit Engage with DentiTrac.
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