De Novo
DEN240021: Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))
FDA De Novo · active protective technologies, inc. · decided Apr 9, 2025
Key facts
| De Novo number | DEN240021 |
|---|---|
| Device name | Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)) |
| Applicant | active protective technologies, inc. |
| Product code | SEC |
| Date received | May 16, 2024 |
| Decision date | Apr 9, 2025 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Physical Medicine |
| FEI number | 3038206342 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 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: