The OpenBCI Ultracortex Mark IV is a fully open-source, 3D-printable EEG headset supporting up to 16 channels via the OpenBCI Cyton + Daisy biosensing boards. Designed for the research, maker, and developer community, all hardware files and firmware are released on GitHub under open-source licenses. The headset uses spring-loaded dry electrode nodes repositionable to any location in the 10-20 system. The OpenBCI GUI provides real-time visualization and recording, with plugins for BrainFlow, Lab Streaming Layer (LSL), and Python. The ecosystem is the de facto standard for open-source BCI development, used in hundreds of university labs worldwide.
This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.
FDA Device Regulatory Guidance ↗