DEN200046 is an FDA 510(k) submission for the Neurolutions Upper Extremity Rehabilitation System. This device is classified as a Electroencephalography (eeg)-driven Upper Extremity Powered Exerciser (Class II - Special Controls, product code QOL).
Submitted by Neurolutions, Inc. (Santa Cruz, US). The FDA issued a Not Cleared (DENG) decision on April 23, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5420. 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..
| 510(k) Number | DEN200046 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 23, 2020 |
| Decision Date | April 23, 2021 |
| Days to Decision | 274 days |
| Submission Type | Direct |
| Review Panel | Physical Medicine (PM) |
| Summary | - |
| Product Code | QOL - Electroencephalography (eeg)-driven Upper Extremity Powered Exerciser |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5420 |
| Definition | 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. |