De Novo
DEN120016: DEKA ARM SYSTEM
FDA De Novo · deka integrated solutions corporation · decided May 9, 2014
Key facts
| De Novo number | DEN120016 |
|---|---|
| Device name | DEKA ARM SYSTEM |
| Applicant | deka integrated solutions corporation |
| Product code | PAE |
| Date received | Jun 15, 2012 |
| Decision date | May 9, 2014 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Physical Medicine |
| FEI number | 1220973 |
At a glance
- None Later 510(k)s citing this De Novo
- 10–99 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: