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U.S. Department of Health and Human Services

Product Classification

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Device foot examination tool for inflammatory changes
Regulation Description Daily activity assist device.
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.
Physical State n/a
Technical Method A device that consists of a 2X convex mirror, surrounded on two sides by liquid crystal pads. These liquid crystal pads react to skin temperature when the patient places his feet on top of them, providing different colors for different temperatures. The device is a daily activity assist device. It provides visible and thermal graphic images of the plantar surface of the foot. It is intended to assist the patient in checking their feet for signs of inflammation as evidence by differences in the thermal patterns of the plantar surface.
Target Area feet
Regulation Medical Specialty Physical Medicine
Review Panel General Hospital
Product CodeOIZ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(K) Exempt
Regulation Number 890.5050
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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