Utah wellness firm warned a second time for promoting device for uncleared uses
The US Food and Drug Administration (FDA) has again sent the Utah-based wellness company Zyto a warning letter for marketing its Zyto Hand Cradle GSR for uses outside its cleared intended use, including to diagnose diseases such as Alzheimer’s, HIV and melanoma in conjunction with the company’s proprietary software.FDA previously warned the company in 2015 for similar issues involving the Hand Cradle device, including for promoting the product for uses that would constitute a major change from its cleared intended use.
FDA investigators inspected Zyto’s Lindon, UT facility in December 2022 and found that many of the same practices it was cited for in the 2015 warning letter are still in practice. The Zyto Hand Cradle GSR is cleared by FDA to measure galvanic skin response, though FDA alleges that the company has continued to claim that by using those measurements, it can make certain diagnoses and recommend treatments for various conditions. FDA notes that the company states that its proprietary software, when used in conjunction with the hand cradle, can identify certain “stressors” and recommend “balancers” as treatments.
Some of the “stressors” the company reportedly claimed to be able to identify or diagnose with the Zyto Hand Cradle GSR with its proprietary software include Alzheimer’s disease, Hepatitis, human immunodeficiency virus (HIV), Parkinson’s disease and melanoma. The FDA notes that the company has not validated the device or its software for the claims it is making.
“The ZYTO Hand Cradle Galvanic Skin Response System was cleared under K111308 only to measure galvanic skin responses,” FDA emphasized. “Despite prior notice from FDA in your 2015 Warning Letter and some corrections made around that time, your firm has added back promotion of the ZYTO Hand Cradle GSR for use in diagnosing diseases or conditions, including determining whether someone responds to a specific allergen, and continues to predict biological responses to a wide range of virtual stimuli including homeopathic nosodes and nutritional supplements.”
FDA also cited the company for not following good manufacturing practices (GMP) and other violations, such as not following Corrective and Preventive Actions (CAPA) procedures.
“Your firm should take prompt action to address any violations identified in this letter,” said FDA.
“The ZYTO Hand Cradle GSR is adulterated and misbranded, and we request that you immediately cease any marketing of this product and its accessories,” the agency added. “Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
The warning letter is dated 21 June, though it was not posted to FDA’s website until 11 July. The agency gave the company 15 working days to respond.
Warning letter
