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QZCClass II

External Mechanical Stimulator For The Relief Of Congestion

21 CFR 874.6010 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QZC is the FDA product code for External Mechanical Stimulator For The Relief Of Congestion, a class II device type, regulated under 21 CFR 874.6010. FDA's definition for this code reads: "The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QZC
Device name
External Mechanical Stimulator For The Relief Of Congestion
FDA definition
The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
Regulation
21 CFR 874.6010
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
2
Ingested recalls
0

Clearances, product code QZC

By decision year
2 clearances under product code QZC with a decision year between 2023 and 2025, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QZC by decision year
YearClearances
20231
20251

Applicants with the most clearances

Product code QZC
Applicants holding the most 510(k) clearances under product code QZC
ApplicantClearances
Sound Health Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code