QOL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5420
- Medical specialty
- Neurology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Neurolutions Upper Extremity Rehabilitation System (DEN200046) | Neurolutions, Inc. | 2021-04-23 |
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