Loading…
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.