Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
The Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion is an ear, nose, and throat device that electrically stimulates the skin overlying the paranasal sinuses to relieve nasal and sinus congestion. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 874.6000 in the Ear, Nose, Throat specialty. It carries product code QNU and is not an implant and not life-sustaining.
Research product code QNU in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QNU
- Device Class
- FDA class 2
- Regulation Number
- 874.6000
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200006 | ClearUP Sinus Relief | Mar 05, 2021 | Unknown | Tivic Health Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.