OIZ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Foot Examination Tool For Inflammatory Changes

Device class

Class I (low risk)

Regulation

21 CFR 890.5050

Medical specialty

Physical Medicine

FDA definition

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.

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