LINDON, UT, May 28, 2015 – ZYTO Technologies Inc., a Utah-based company specializing in biocommunication applications, is actively working with the Food and Drug Administration to clarify and modify promotional language associated with the labeling of the ZYTO Hand Cradle, a Class II medical device.
In 2011, the ZYTO Hand Cradle was cleared by the Food and Drug Administration as a Class II medical device used to gather Galvanic Skin Response data. In November 2014, ZYTO completed its first audit by the FDA. The FDA audit covered all aspects of our manufacturing processes as well as all messaging relating to the ZYTO medical device. On May 8, 2015, the FDA issued a letter to ZYTO outlining a few messaging issues that they would like ZYTO to modify.
“We welcome this input from the FDA,” said Kami Howard, President and COO of ZYTO. “We have a strong desire to represent ZYTO products to our customers accurately and clearly. We have already addressed each specific issue raised by the FDA. ZYTO is committed to being fully compliant with all applicable laws and regulations.”
Considering that this was our first FDA audit, ZYTO is pleased that the requested corrective actions can be addressed quickly and fully and will not detract from business operations.
Contact information: info@ZYTO.com