QOL

Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

Product code

QOL

Device name

Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

Device class

Class 2

21 CFR

21 CFR 890.5420

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).