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 (last 3 years): 1

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).

Official FDA classification page: QOL

Classification and pathway per current FDA publications. Data from openFDA (CC0).