Second Warning To Utah Company For Promoting Device Outside Intended Use

The US Food and Drug Administration issued a warning letter to ZYTO Technologies for marketing its Hand Cradle Galvanic Skin Response device for purposes outside the scope of its authorized use.

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After an inspection of a ZYTO Technologies facility in Lindon, Utah in December 2022, the US Food and Drug Administration issued a warning letter to the company on 21 June for promoting its Hand Cradle Galvanic Skin Response (GSR) device — and its associated proprietary software — for uses for which it did not have FDA clearance.

The device, the FDA emphasizes, was cleared solely to measure galvanic skin responses, which are changes in the sweat glands...

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