FDA product code QYN: Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
QYN is the FDA product code for prescription audiovisual stimulator (avs) for temporary pain relief (adjunctive use). It is a Class I device, regulated under 21 CFR 890.5775 and reviewed by the Neurology panel. Devices under QYN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies
Classification
| Field | Value |
|---|---|
| Device name | Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) |
| Device class | Class I |
| Regulation | 21 CFR 890.5775 |
| Review panel | NE — Neurology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for QYN devices
openFDA lists no recalls for product code QYN.
Frequently asked questions
What is FDA product code QYN?
QYN is the FDA product code for prescription audiovisual stimulator (avs) for temporary pain relief (adjunctive use). It is a Class I device, regulated under 21 CFR 890.5775 and reviewed by the Neurology panel.
What device class is QYN?
Class I, regulation 21 CFR 890.5775. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QYN
- Run a recall and safety report across every QYN manufacturer
- Watch product code QYN 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times