ZYTO Technologies, Inc.

Warning LetterOpen

Dr. Vaughn R. Cook Chairman and Owner/Founder ZYTO Technologies, Inc. 1172 W. 700 N., Suite 300 Lindon , UT 84042 United StatesFEI 3008493238Issued Jun 21, 2023Division of Medical Device and Radiological Health Operations West

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3008493238.

Violations12

Issue DateJun 21, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: ZYTO Technologies, Inc.
Location: Dr. Vaughn R. Cook Chairman and Owner/Founder ZYTO Technologies, Inc. 1172 W. 700 N., Suite 300 Lindon , UT 84042 United States
FEI Number: 3008493238
Country: United States
Issue Date: June 21, 2023
Issuing Office: Division of Medical Device and Radiological Health Operations West
Product Type: Medical Devices
Status: Open

Summary

ZYTO Technologies, Inc. manufactured the ZYTO Hand Cradle Galvanic Skin Response (GSR) device and associated software that claimed to identify disease "stressors" and "balancers" for conditions including Alzheimer's disease, HIV, Parkinson's disease, and melanoma, thereby qualifying the product as a medical device under FDA jurisdiction. The company violated Federal Food, Drug, and Cosmetic Act requirements by marketing an adulterated device without an approved Premarket Approval (PMA) application or Investigational Device Exemption (IDE), and by failing to submit the required 510(k) premarket notification prior to commercial distribution. An FDA inspection conducted in December 2022 at the company's Lindon, Utah facility identified these violations and prompted the warning letter issued in June 2023.

ZYTO Technologies, Inc. FDA Warning Letter, June 21, 2023