Foot Examination Tool for Inflammatory Changes

What Is It?

Assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. The device will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. Intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.

What Is FDA Product Code OIZ?

Foot Examination Tool For Inflammatory Changes is FDA product code OIZ, Class 1, 21 CFR 890.5050.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.