Sana Health: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Sana Health”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QYN | Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250005 | De Novo | Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) | 2026-01-16 |
Recalls
openFDA lists no recalls under a recalling firm named Sana Health.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Sana Health is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05319405: Effectiveness of Sana Treatment in Post-Traumatic Stress Disorder (PTSD) (Completed, started 2023-04-19)
- NCT04568798: Efficacy of Sana Treatment in Fibromyalgia (Completed, started 2020-07-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sana Health?
FDA lists 0 510(k) clearances under the applicant name “Sana Health”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Sana Health?
The most frequent FDA product codes under this applicant name are QYN (Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use), 1).
Next steps
- See all 0 Sana Health clearances with predicates and recalls
- Run predicate analysis for product code QYN, Sana Health's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.