QNUClass II
Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
21 CFR 874.6000 / Ear, Nose, Throat
QNU is the FDA product code for Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion, a class II device type, regulated under 21 CFR 874.6000. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QNU
- Device name
- Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
- 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.
- Regulation
- 21 CFR 874.6000
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QNU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
Applicants with the most clearances
Product code QNU| Applicant | Clearances |
|---|---|
| Tivic Health Systems, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QNU.
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