QOL · Class II · 21 CFR 890.5420

FDA Product Code QOL: Electroencephalography (eeg)-driven Upper Extremity Powered Exerciser

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.

Leading manufacturers include Neurolutions, Inc..

1
Total
0
Cleared
274d
Avg days
2021
Since

FDA 510(k) Cleared Electroencephalography (eeg)-driven Upper Extremity Powered Exerciser Devices (Product Code QOL)

1 devices
1–1 of 1
Not Cleared Apr 23, 2021
Neurolutions Upper Extremity Rehabilitation System
DEN200046
Neurolutions, Inc.
Physical Medicine · 274d

About Product Code QOL - Regulatory Context

QOL devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →