Search Results
Found 1 results
510(k) Data Aggregation
K Number
K150941Device Name
Somnowell Mandibular Advancement Appliance (MAA)
Manufacturer
Date Cleared
2015-05-22
(44 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Somnowell Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.
Device Description
The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is a removable intraoral device used for treating night time snoring and mild to moderate obstructive sleep apnea. It consists of two customized fabricated chrome cobalt (Vitallium 2) frameworks that conform to the patient's dentition in the upper and lower jaws and are connected bilaterally via a stainless steel telescoping Herbst device. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to improve the patient's ability to breathe during sleep without obstruction of the pharyngeal airway. The device is customized according to the prescription of the prescribing dentist for each patient. It has an adjustment mechanism enabling the amount of mandibular advancement to be set or altered by the dentist. The maximum protrusion and allowable increments of adjustment are 5mm.
Ask a Question
Ask a specific question about this device
Page 1 of 1