510(k) DEN200046
DEN200046 is an FDA 510(k) premarket notification submitted by Neurolutions, Inc. for the device "Neurolutions Upper Extremity Rehabilitation System". The FDA issued a decision of De Novo granted on Apr 23, 2021. The device falls under product code QOL (Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser), a Class II device regulated under 21 CFR 890.5420.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Apr 23, 2021
- Date Received
- Jul 23, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
- Device Class
- Class II
- Regulation Number
- 890.5420
- Review Panel
- PM
- Submission Type
- 510(k)
An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.