FDA WARNING_LETTER - ZYTO Technologies, Inc. - December 03, 2014

On November 14, 2014, through December 3, 2014, the FDA inspected ZYTO Technologies, Inc., which manufactures the ZYTO Hand Cradle (a Class II galvanic skin response device), ZYTO Laser, and ZYTO Tower. The inspection resulted in an eleven-item FDA Form 483. The FDA deemed ZYTO's December 22, 2014, response inadequate regarding labeling and promotion.

The ZYTO Hand Cradle is adulterated under section 501(f)(1)(B) of the Act because ZYTO lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) for major changes to its intended use without a new premarket notification (510(k)). The device was cleared for galvanic skin response measurement, but ZYTO's promotion on its website and in brochures indicates uses such as diagnosing disease, predicting biological responses to stimuli (e.g., drugs, supplements), and identifying allergen responses, which are uncleared.

Additionally, the ZYTO Laser and ZYTO Tower, intended as accessories for the Hand Cradle, are adulterated under section 501(f)(1)(B) due to the lack of approved PMAs or IDEs, and misbranded under section 502(o)