Lifeline Biotechnologies Inc (LLBO)

[Domains]

iTbra is now a Class I device: Class I devices are subject to the least regulatory control
https://www.fda.gov/ForPatients/Approvals/Devices/ucm405381.htm

According to the latest CISCO interview to Rob Royea
Most exempt from premarket submission (Class I)

Federal Food, Drug, and Cosmetic Act, section 513, established the risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes: Class I, Class II or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness.

As device class increases from Class I, to Class II to Class III, the regulatory controls also increase, with Class I devices subject to the least regulatory control, and Class III devices subject to the most regulatory control.