De Novo
DEN250044: STEMI AI ECG Model
FDA De Novo · powerful medical, inc. · decided Sep 3, 2026
Key facts
| De Novo number | DEN250044 |
|---|---|
| Device name | STEMI AI ECG Model |
| Applicant | powerful medical, inc. |
| Product code | SHS |
| Date received | Sep 22, 2025 |
| Decision date | Sep 3, 2026 |
| Decision | granted (DENG) |
| FDA classification | Not classified |
| Review panel | Missing Review Panel |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: