De Novo DEN130034
- Device
- REWALK
- Contact
- john v hamilton
- De Novo number
- DEN130034
- Product code
- PHL
- Regulation
- 890.3480
- Classification name
- powered exoskeleton
- Decision
- granted (DENG)
- Decision date
- 2014-06-26
- Date received
- 2013-06-17
- Classification advisory
- Physical Medicine
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- PHL
- Device name
- Powered Exoskeleton
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation
- 890.3480
- Implant
- N
- Life sustain/support
- N