What does it mean if something is FDA class 2 approved?

Question

I have been asked to take a test called biomeredian stress test I am still trying to figure out if I want to pay for this. I found in my research that it is FDA approved class 2 and I have no idea what that means. I was ordered this test by my doctor who is a licensed doctor!

Answer 1

Class II: General Controls with Special Controls

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance.[2] Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, and acupuncture needles.