De Novo DEN200046
- Device
- Neurolutions Upper Extremity Rehabilitation System
- Contact
- kern j. bhugra
- De Novo number
- DEN200046
- Product code
- QOL
- Regulation
- 890.5420
- Classification name
- electroencephalography (eeg)-driven upper extremity powered exerciser
- Decision
- granted (DENG)
- Decision date
- 2021-04-23
- Date received
- 2020-07-23
- Classification advisory
- Neurology
- Review advisory
- Physical Medicine
- Type
- Direct
Current FDA Classification#
- Product code
- QOL
- Device name
- Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 890.5420
- Implant
- N
- Life sustain/support
- N