510(k) DEN250005
- Device
- Sana Device
- Applicant
- Sana Health
- 510(k) number
- DEN250005
- Product code
- QYN
- Decision
- Unknown (DENG)
- Decision date
- 2026-01-16
- Date received
- 2025-03-03
- Regulation
- 890.5775
- Classification name
- Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Richard Hanbury
- Address
- 2051 Dogwood St., Suite 220 Louisville CO US 80027 80027
Source Documents
510(k) summary PDF not indicated by FDA