510(k) K132003
K132003 is an FDA 510(k) premarket notification submitted by Apnicure, Inc. for the device "WINX SLEEP THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 2014. The device falls under product code OZR (Intraoral Pressure Gradient Device), a Class II device regulated under 21 CFR 872.5570. Apnicure, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2014
- Date Received
- July 1, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraoral Pressure Gradient Device
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- AN
- Submission Type
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.