Sonu (Gray Headband)
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 22 and older.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Sound Health Systems, Inc., United States |
|---|---|
| FDA product code | QZC |
| Device type | External Mechanical Stimulator For The Relief Of Congestion |
| Device class | Class 2 |
| Regulation | 21 CFR 874.6010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | DEN230045 |
| Record published | 2024-03-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHS-HW-001A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sonu (Black Headband) | Sound Health Systems, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242214 | 2025-04-24 |
| DEN230045 | 2023-12-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.