K242214 is an FDA 510(k) clearance for the Sonu. This device is classified as a External Mechanical Stimulator For The Relief Of Congestion (Class II - Special Controls, product code QZC).
Submitted by Sound Health Systems, Inc. (Los Altos, US). The FDA issued a Cleared decision on April 24, 2025, 269 days after receiving the submission on July 29, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.6010. The External Mechanical Stimulator For The Relief Of Congestion Delivers Vibrations To The Sinus And Nasal Areas To Relieve Congestion..
| 510(k) Number | K242214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2024 |
| Decision Date | April 24, 2025 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | QZC - External Mechanical Stimulator For The Relief Of Congestion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.6010 |
| Definition | The External Mechanical Stimulator For The Relief Of Congestion Delivers Vibrations To The Sinus And Nasal Areas To Relieve Congestion. |