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U.S. Department of Health and Human Services

Product Classification

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Device electroencephalography (eeg)-driven upper extremity powered exerciser
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.
Physical State Device includes components for recording EEG signals, moving the hand, and controlling the program.
Technical Method The device relies on signals recorded through EEG to encode movement intention and pairs that with movement of the hand.
Target Area Upper limb rehabilitation
Regulation Medical Specialty Neurology
Review Panel Physical Medicine
Product CodeQOL
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5420
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible