Atlas FDA

QZC

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
External Mechanical Stimulator For The Relief Of Congestion
Device class
Class II (moderate risk)
Regulation
21 CFR 874.6010
Medical specialty
Ear, Nose, Throat
FDA definition
The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
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RecordFirmDate
Sonu (K242214)Sound Health Systems, Inc.2025-04-24
Sonu (DEN230045)Sound Health Systems, Inc.2023-12-04

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