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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeQOL
Regulation Number 890.5420
Device Class 2


Premarket Reviews
ManufacturerDecision
NEUROLUTIONS, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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