QNU — Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion Class II
FDA product code QNU covers "Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion", a Class II medical device regulated under 21 CFR 874.6000. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QNU
- Device Class
- Class II
- Regulation Number
- 874.6000
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200006 | tivic health systems | ClearUP Sinus Relief | March 5, 2021 |