QZC
- Product code
- QZC
- Device name
- External Mechanical Stimulator For The Relief Of Congestion
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.6010
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242214 | 2025-04-24 | Sound Health Systems, Inc. | Sonu | |
| DEN230045 | 2023-12-04 | Sound Health Systems, Inc. | Sonu | — |
Official FDA classification page: QZC
Classification and pathway per current FDA publications. Data from openFDA (CC0).