NeuroField, Inc.

Warning LetterOpen

Nicholas J. Dogris CEO & Co-Founder/Co-Owner NeuroField, Inc. 386 West Line Street Bishop , CA 93514-3413 United States nicholasdogris@verizon.netFEI 3010900508Issued Feb 28, 2022Center for Devices and Radiological Health

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Violations9

Issue DateFeb 28, 2022

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: NeuroField, Inc.
Location: Nicholas J. Dogris CEO & Co-Founder/Co-Owner NeuroField, Inc. 386 West Line Street Bishop , CA 93514-3413 United States nicholasdogris@verizon.net
FEI Number: 3010900508
Country: United States
Issue Date: February 28, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

NeuroField, Inc. FDA Warning Letter, February 28, 2022