Product code
QNU: Transcutaneous electrical nerve stimulator for the relief of congestion
FDA product code · Class II · Ear Nose & Throat
Key facts
| Product code | QNU |
|---|---|
| Device | Transcutaneous electrical nerve stimulator for the relief of congestion |
| Device class | Class II |
| Regulation number | 874.6000 |
| Review panel | Ear Nose & Throat |
| Medical specialty | Ear Nose & Throat |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | 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. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database