K193460 is an FDA 510(k) clearance for the The iNAP One Sleep Therapy System. This device is classified as a Intraoral Pressure Gradient Device (Class II - Special Controls, product code OZR).
Submitted by Somnice, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on May 26, 2020, 162 days after receiving the submission on December 16, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 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..
| 510(k) Number | K193460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2019 |
| Decision Date | May 26, 2020 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | OZR - Intraoral Pressure Gradient Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
| 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. |