FDA product code OIZ: Foot Examination Tool For Inflammatory Changes
OIZ is the FDA product code for foot examination tool for inflammatory changes. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under OIZ, from 2 different applicants. The average 510(k) review took 155 days (median 155).
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.
Classification
| Field | Value |
|---|---|
| Device name | Foot Examination Tool For Inflammatory Changes |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | HO — General Hospital |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OIZ clearance
Top OIZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Podimetrics,Inc. | 1 | 2015-10-08 |
| Visual Footcare Technologies, LLC | 1 | 2008-06-24 |
Most recent OIZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150557 | Podimetrics,Inc. | Podimetrics Remote Temperature Monitoring System | 2015-10-08 | 218 |
| K080816 | Visual Footcare Technologies, LLC | VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT | 2008-06-24 | 92 |
Recalls for OIZ devices
openFDA lists no recalls for product code OIZ.
Frequently asked questions
What is FDA product code OIZ?
OIZ is the FDA product code for foot examination tool for inflammatory changes. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel.
What device class is OIZ?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OIZ?
Across 2 cleared submissions the average was 155 days from receipt to decision (median 155).
Which companies have the most OIZ clearances?
Podimetrics,Inc. (1); Visual Footcare Technologies, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OIZ
- Run a recall and safety report across every OIZ manufacturer
- Watch product code OIZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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