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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intraoral pressure gradient device
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 CodeOZR
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
APNICURE, INC.
  SUBSTANTIALLY EQUIVALENT 4
SOMNICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOMNICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Reprocessing Problem 1 1
Patient-Device Incompatibility 1 1
Device Contamination With Biological Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Pain 1 1

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