Bioelectronics Corp (BIEL)

[Jonnyo07]

Ok I see, here is FDA’s interpretation of device classification:

Classification of Medical Devices

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk.