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510(k) Data Aggregation
K Number
K080816Device Name
VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
Manufacturer
Date Cleared
2008-06-24
(92 days)
Product Code
Regulation Number
890.5050Why did this record match?
Applicant Name (Manufacturer) :
VISUAL FOOTCARE TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TempStat" is a daily activity assist device that is intended to 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. TempStat" 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. TempStat™ is 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.
Device Description
The Visual Footcare Technologies TempStat® device is a daily activity assist designed to make the examination of the plantar surface of the foot simple and easy to accomplish. It consists of a plastic pancl that has a 2X convex mirror in the center third scction, with two polycarbonate plastic pads on either side of the mirror. The plastic pads are contructed primarily of liquid crystallinc cholesteric esters that react to skin surface temperature and change to a specific color relative to that level of temperature. With this device, the patient can visually examine his foot and also see a graphical representation of the heat pattern on the plantar solc of his foot. The device is designed to sit on the floor in front of the patient, who is seated in a chair. The patient leans over and raises his foot to see the bottom of his foot in the mirror, and then places them on the polycarbonate pads. After 60 seconds, the patient can remove his feet and can visualize the pattern of skin tempcrature from the plantar surface of his foot.
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