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NeuroField, Inc. manufactured neurostimulation and EEG signal processing devices (NeuroField X3000/X3000 Plus, NeuroField Q21, NeuroField64, and NeuroField EEG) without obtaining required FDA premarket approval (PMA) or investigational device exemption (IDE) authorization, rendering the devices adulterated under Section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company also failed to submit the required premarket notification (510(k)) before introducing these devices into commercial distribution, violating Section 502(o) misbranding requirements. An FDA inspection conducted in September-October 2021 at the company's Bishop, California facility identified these violations through review of company operations and website marketing claims.