DEN250005 is an FDA 510(k) submission for the Sana Device. This device is classified as a Prescription Audiovisual Stimulator (avs) For Temporary Pain Relief (adjunctive Use) (Class I - General Controls, product code QYN).
Submitted by Sana Health (Louisville, US). The FDA issued a Not Cleared (DENG) decision on January 16, 2026.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.5775. An Avs Is A Prescription Use Device Intended For Temporary Pain Relief And Is Used Adjunctively With Other Pain Therapies.
| 510(k) Number | DEN250005 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 03, 2025 |
| Decision Date | January 16, 2026 |
| Days to Decision | 319 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QYN - Prescription Audiovisual Stimulator (avs) For Temporary Pain Relief (adjunctive Use) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5775 |
| Definition | An Avs Is A Prescription Use Device Intended For Temporary Pain Relief And Is Used Adjunctively With Other Pain Therapies |