FDA product code QOL

Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

Neurology·Class 2·21 CFR 890.5420
US regulatory classifications
US Product Code (FDA)
QOL
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 890.5420
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.