Product code QOL— Neurology
Neurolutions Upper Extremity Rehabilitation System
- Classification name
- Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
- Device class
- Class 2
- Regulation
- 21 CFR 890.5420
- Advisory panel
- Neurology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QOL
FDA has cleared device under product code QOL, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QOL
Recent clearances under product code QOL
Data sourced from openFDA. This site is unofficial and independent of the FDA.