510(k) DEN120016
DEN120016 is an FDA 510(k) premarket notification submitted by Deka Integrated Solutions Corporation for the device "DEKA ARM SYSTEM". The FDA issued a decision of De Novo Granted on May 9, 2014. The device falls under product code PAE (Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography), a Class II device regulated under 21 CFR 890.3450.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 9, 2014
- Date Received
- June 15, 2012
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
- Device Class
- Class II
- Regulation Number
- 890.3450
- Review Panel
- PM
- Submission Type
Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality.