QOL — Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser Class II
FDA product code QOL covers "Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser", a Class II medical device regulated under 21 CFR 890.5420. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QOL
- Device Class
- Class II
- Regulation Number
- 890.5420
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200046 | neurolutions | Neurolutions Upper Extremity Rehabilitation System | April 23, 2021 |