Grapefruit USA Inc (GPFT)

[mr_sano]

Yes I get it

501K =SE.

PMA=Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices.

Do you know what special controls DVIS uses? Is it failsafe in all modes of operation? What level of REE has been measured in all modes of intended use. How is this measured? Dean claims lower exposure but whats the data say per procedure? Do know this or link to it. PLease educate us?