Search Results
Found 1 results
510(k) Data Aggregation
K Number
K190353Device 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
872.5570Why 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.
Ask a Question
Page 1 of 1