QZC

External Mechanical Stimulator For The Relief Of Congestion

Product code
QZC
Device name
External Mechanical Stimulator For The Relief Of Congestion
Device class
Class 2
21 CFR
21 CFR 874.6010
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-04-24.

NumberDecision dateApplicantDevice nameSummary
K2422142025-04-24Sound Health Systems, Inc.SonuPDF
DEN2300452023-12-04Sound Health Systems, Inc.Sonu

1 summaries are archived here for direct download.

Official FDA classification page: QZC
Classification and pathway per current FDA publications. Data from openFDA (CC0).