Product code QZC
- Device name
- External Mechanical Stimulator For The Relief Of Congestion
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.6010
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K242214 | Sonu | Sound Health Systems, Inc. | 2025-04-24 |
| DEN230045 | Sonu | Sound Health Systems, Inc. | 2023-12-04 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00860009781207 | Sonu (Black Headband) | Sound Health Systems Inc | 2024-03-09 |
| 10860009781259 | Sonu (Gray Headband) | Sound Health Systems Inc | 2024-03-09 |