QNU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.6000
- Medical specialty
- Ear, Nose, Throat
- FDA definition
- A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ClearUP Sinus Relief (DEN200006) | Tivic Health Systems, Inc. | 2021-03-05 |
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Every clearance here is in the API, with alerts when new ones post.