QYN — Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) Class I
FDA product code QYN covers "Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)", a Class I medical device regulated under 21 CFR 890.5775. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QYN
- Device Class
- Class I
- Regulation Number
- 890.5775
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250005 | Sana Health | Sana Device | Jan 16, 2026 |