The following data is part of a De Novo classification by Deka Integrated Solutions Corporation with the FDA for Deka Arm System.
| DeNovo ID | DEN120016 |
| Device Name: | DEKA ARM SYSTEM |
| Classification | Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography |
| Applicant | DEKA INTEGRATED SOLUTIONS CORPORATION 340 Commercial Street Manchester, NH 03101 |
| Contact | Roger Leroux |
| Product Code | PAE |
| CFR Regulation Number | 890.3450 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K121215 |
| Review Advisory Board | Physical Medicine |
| Classification Advisory | Physical Medicine |
| Type | Post-NSE |
| Date Received | 2012-06-15 |
| Decision Date | 2014-05-09 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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