FDA product code QVN: Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
QVN is the FDA product code for combined acoustic and electrical external stimulation device for the relief of tinnitus. It is a Class II device, regulated under 21 CFR 874.3410 and reviewed by the Ear, Nose and Throat panel. Devices under QVN reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus.
Classification
| Field | Value |
|---|---|
| Device name | Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus |
| Device class | Class II |
| Regulation | 21 CFR 874.3410 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Recalls for QVN devices
openFDA lists no recalls for product code QVN.
Frequently asked questions
What is FDA product code QVN?
QVN is the FDA product code for combined acoustic and electrical external stimulation device for the relief of tinnitus. It is a Class II device, regulated under 21 CFR 874.3410 and reviewed by the Ear, Nose and Throat panel.
What device class is QVN?
Class II, regulation 21 CFR 874.3410. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QVN
- Run a recall and safety report across every QVN manufacturer
- Watch product code QVN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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