Product Classification

• Device: electrode, cutaneous
• Regulation Description: Cutaneous electrode.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GXY
• Premarket Review: Neuromodulation and Physical Medicine Devices (DHT5B); Neuromodulation and Physical Medicine Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 882.1320
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 3-52 ANSI AAMI EC12:2000/(R)2015
  Disposable ECG electrodes
• 17-13 IEEE Std 2010-2012
  Recommended Practice for Neurofeedback Systems
• 17-18 IEEE Std 2010-2023
  Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems

Guidance Document

• Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

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