# Foot Examination Tool For Inflammatory Changes
> **Product code: OIZ** · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.5050
## Classification
- **FDA Product Code:** OIZ
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 890.5050
- **Review panel:** HO
- **Medical specialty:** Physical Medicine
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 14
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OIZ)
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