OIZ — Foot Examination Tool For Inflammatory Changes Class I
FDA product code OIZ covers "Foot Examination Tool For Inflammatory Changes", a Class I medical device regulated under 21 CFR 890.5050. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OIZ
- Device Class
- Class I
- Regulation Number
- 890.5050
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Physical Medicine
- Implant
- No
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.