Product code QOL
- Device name
- Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 890.5420
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN200046 | Neurolutions Upper Extremity Rehabilitation System | Neurolutions, Inc. | 2021-04-23 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00850005539018 | Neurolutions Ipsihand Upper Extremity Rehabilitation System | Neurolutions, Inc | 2022-09-12 |
| 00850005539025 | Neurolutions Ipsihand Upper Extremity Rehabilitation System | Neurolutions, Inc | 2022-09-12 |