Device |
intraoral pressure gradient device |
Regulation Description |
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. |
Definition |
This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that urges the soft palate and tongue forward. It is intended to be used while a patient is sleeping to treat obstructive sleep apnea. |
Product Code | OZR |
Regulation Number |
872.5570
|
Device Class |
2
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