Skip to contentDe Novo DEN250005
- Device
- Sana Device
- Contact
- richard hanbury
- De Novo number
- DEN250005
- Product code
- QYN
- Regulation
- 890.5775
- Classification name
- prescription audiovisual stimulator (avs) for temporary pain relief (adjunctive use)
- Decision
- granted (DENG)
- Decision date
- 2026-01-16
- Date received
- 2025-03-03
- Classification advisory
- Physical Medicine
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QYN
- Device name
- Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation
- 890.5775
- Implant
- N
- Life sustain/support
- N