QZC
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- External Mechanical Stimulator For The Relief Of Congestion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.6010
- Medical specialty
- Ear, Nose, Throat
- FDA definition
- The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Sonu (K242214) | Sound Health Systems, Inc. | 2025-04-24 |
| Sonu (DEN230045) | Sound Health Systems, Inc. | 2023-12-04 |
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