Intraoral Pressure Gradient Device
Dental · 21 CFR 872.5570
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.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Somnics, Inc.Jun 16, 2023
K220907 · The iNAP One Sleep Therapy System
- Somnice, Inc.May 26, 2020
K193460 · The iNAP One Sleep Therapy System
- Apnicure, Inc.Jun 13, 2014
K132003 · WINX SLEEP THERAPY SYSTEM
- Apnicure, Inc.May 22, 2013
K130538 · WINX SLEEP THERAPY SYSTEM
- Apnicure, Inc.Oct 31, 2012
K122130 · WINX SLEEP THERAPY SYSTEM
- Apnicure, Inc.Mar 30, 2012
K111549 · ATTUNE SLEEP APNEA SYSTEM