QYN
- Product code
- QYN
- Device name
- Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
- Device class
- Class 1
- 21 CFR
- 21 CFR 890.5775
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 1
FDA classification definition
An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN250005 | 2026-01-16 | Sana Health | Sana Device | — |
Official FDA classification page: QYN
Classification and pathway per current FDA publications. Data from openFDA (CC0).