Product Classification

• Device: full-montage standard electroencephalograph
• Regulation Description: Electroencephalograph.
• Definition: Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
• Physical State: May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, more complex software used to analyze electroencephalograph data or automatically detect events, electroencephalograph used for polysomnography or sleep studies, or electroencephalograph with less than 16 electrodes.
• Technical Method: Uses electrodes (16 or more) placed on the scalp or within the brain, via user-specified locations, to record and display electrical activity of the brain
• Target Area: Brain
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GWQ
• Premarket Review: Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 882.1400
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 17-13 IEEE Std 2010-2012
  Recommended Practice for Neurofeedback Systems
• 17-18 IEEE Std 2010-2023
  Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc