DeviceClearance

Product code QZC— Ear, Nose, Throat

Sonu

Classification name
External Mechanical Stimulator For The Relief Of Congestion
Device class
Class 2
Regulation
21 CFR 874.6010
Advisory panel
Ear, Nose, Throat
Total cleared
2
First cleared
Most recent

FDA classification definition

“The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.”

— U.S. Food and Drug Administration, device classification record for product code QZC under 21 CFR 874.6010, via openFDA

Market context for product code QZC

FDA has cleared 2 devices under product code QZC between 2023 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QZC

Recent clearances under product code QZC

Data sourced from openFDA. This site is unofficial and independent of the FDA.