# K150557: Podimetrics Remote Temperature Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Podimetrics,Inc.
- Decided: Oct 8, 2015 after 218 days
- Product code: OIZ (Foot Examination Tool For Inflammatory Changes)
- Device class: 1
- Regulation: 21 CFR 890.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K760293 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080816: Visual Footcare Technologies Tempstat, Visual Footcare Technologies, LLC (2008) Summary page 4.

## Indications for use
The Podimetrics Remote Temperature Monitoring System™ (RTM System™) is intended to be used by a patient in conjunction with a healthcare professional or caretaker for periodic evaluation of the temperature over the soles of the feet for signs of inflammation. It will provide information indicating when the patient and healthcare provider should communicate for further evaluation and treatment regarding any persistent localized inflammation observed on the feet via the electronic sensing system and remote visualization of its data. The Podimetrics RTM System™ is intended to be used under the direction of a healthcare professional as an adjunct to, and not in replacement of, self-examination and periodic foot care and examination conducted by a healthcare professional and does not diagnose any specific disease state.

Source page: https://510kreport.com/device/K150557
Methodology: https://510kreport.com/methodology