Data / Medical devices / United States / Sana Health, Inc.
Sana Health, Inc.: FDA-registered device maker in Louisville, CO, United States, 1 510(k) clearance
Sana Health, Inc. is registered with the FDA (registration 3023815184) in Louisville, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3023815184
- Address
- 2051 Dogwood St. Ste 110, Louisville, CO, United States, 80027
- Owner or operator
- Sana Health, Inc. (10095956)
- Roles
- Manufacturer
- First device listed
- May 28, 2026
- Registered through
- 2027
- Brand names listed
- Sana
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) | QYN | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 16, 2026 | DEN250005 | Sana Device | QYN | Unknown | Sana Health | accessdata.fda.gov |
Updated January 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.