510(k) DEN250005
DEN250005 is an FDA 510(k) premarket notification submitted by Sana Health for the device "Sana Device". The FDA issued a decision of De Novo Granted on Jan 16, 2026. The device falls under product code QYN (Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)), a Class I device regulated under 21 CFR 890.5775.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Jan 16, 2026
- Date Received
- Mar 3, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 890.5775
- Review Panel
- NE
- Submission Type
An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies