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FDA PRODUCT CODE · CLASS II

QZC — External Mechanical Stimulator For The Relief Of Congestion

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

DEVICE CLASS
Class II
REGULATION
21 CFR 874.6010
MEDICAL SPECIALTY
Ear, Nose, Throat
REVIEW PANEL
EN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K242214Sound Health Systems, Inc. · 510k2025-04-24

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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