510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OIZClass I

Foot Examination Tool For Inflammatory Changes

21 CFR 890.5050 / Physical Medicine
FDA source (opens on fda.gov)

OIZ is the FDA product code for Foot Examination Tool For Inflammatory Changes, a class I device type, regulated under 21 CFR 890.5050. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OIZ
Device name
Foot Examination Tool For Inflammatory Changes
FDA 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.
Regulation
21 CFR 890.5050
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code OIZ

By decision year
2 clearances under product code OIZ with a decision year between 2008 and 2015, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OIZ by decision year
YearClearances
20081
20151

Applicants with the most clearances

Product code OIZ
Applicants holding the most 510(k) clearances under product code OIZ
ApplicantClearances
Podimetrics, Inc.1
Visual Footcare Technologies, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code