Clearance Summary
Sana Device received FDA 510(k) clearance under submission number DEN250005, sponsored by Sana Health. The device was reviewed via the Direct premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2026-01-16.
- Submission: DEN250005
- Applicant / Sponsor: Sana Health
- Clearance pathway: Direct
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5775
- Decision date: 2026-01-16
Classification & Regulation
This clearance is catalogued under FDA product code QYN and 21 CFR 890.5775, within the Physical Medicine review panel as a Class I device.