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Second Warning To Utah Company For Promoting Device Outside Intended Use

 
• By Brian Bossetta

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.

• Source: Shutterstock

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 that reflect emotional arousal, such as changes in

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