510(k) K080816
K080816 is an FDA 510(k) premarket notification submitted by Visual Footcare Technologies, LLC for the device "VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT". The FDA issued a decision of Substantially Equivalent on June 24, 2008. The device falls under product code OIZ (Foot Examination Tool For Inflammatory Changes), a Class I device regulated under 21 CFR 890.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2008
- Date Received
- March 24, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Foot Examination Tool For Inflammatory Changes
- Device Class
- Class I
- Regulation Number
- 890.5050
- Review Panel
- HO
- Submission Type
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.