FDA Product Code 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.
Leading manufacturers include Sound Health Systems, Inc..
FDA 510(k) Cleared External Mechanical Stimulator For The Relief Of Congestion Devices (Product Code QZC)
About Product Code QZC - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QZC since 2023, with 1 receiving FDA clearance (average review time: 220 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QZC have taken an average of 269 days to reach a decision - up from 171 days historically. Manufacturers should account for longer review timelines in current project planning.
QZC devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →