DeviceClearance

Product code OIZ— Physical Medicine

Podimetrics Remote Temperature Monitoring System

Classification name
Foot Examination Tool For Inflammatory Changes
Device class
Class 1
Regulation
21 CFR 890.5050
Advisory panel
Physical Medicine
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OIZ under 21 CFR 890.5050, via openFDA

Market context for product code OIZ

FDA has cleared 2 devices under product code OIZ between 2008 and 2015, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code OIZ

Recent clearances under product code OIZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.