Product Classification

• Device: reduced- montage standard electroencephalograph
• Regulation Description: Electroencephalograph.
• Definition: Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
• Physical State: May include standard EEG recording hardware (e.g. headbox, cables, CPU, monitor and basic software (needed to display, store and archive EEG and allow user-only annotation and marking); does NOT include electrodes, more complex software used to analyze EEG or automatically detect events, EEG used for PSG or sleep studies, or EEG with > 16 electrodes or more electrodes.
• Technical Method: Uses electrodes (less than < 16) placed on the scalp or within the brain, via user-specified and/or sponsor-specified locations, to record and display electrical activity of the brain
• Target Area: Brain
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: OMC
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); 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