$GTCH It is intended that the device will be filed under PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES, Subpart C - General Hospital and Personal Use Monitoring Devices as a clinical electronic device that is used to measure body vital of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The device's classification is estimated to be Class I/II and it is expected that it will be determined by the FDA further review. FDA approval means formal approval as a medical device to be marketed and sold in the U.S. This type of certification is essential to ensure the device's safety, accuracy, and effectiveness for public use.

https://www.wsj.com/articles/gbt-seeks-fda-ap...31?tesla=y