QNU — Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
DEN200006tivic health systemsClearUP Sinus ReliefMarch 5, 2021