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De Novo DEN120016
- Device
- DEKA ARM SYSTEM
- Contact
- roger leroux
- De Novo number
- DEN120016
- Product code
- PAE
- Regulation
- 890.3450
- Classification name
- upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography
- Decision
- granted (DENG)
- Decision date
- 2014-05-09
- Date received
- 2012-06-15
- Classification advisory
- Physical Medicine
- Review advisory
- Physical Medicine
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PAE
- Device name
- Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation
- 890.3450
- Implant
- N
- Life sustain/support
- N