510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080816Substantially Equivalent

Visual Footcare Technologies Tempstat

Visual Footcare Technologies, LLC, South Salem NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080816 is the FDA 510(k) clearance record for VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT, a class I device, cleared for Visual Footcare Technologies, LLC on under FDA product code OIZ (Foot Examination Tool For Inflammatory Changes). FDA's definition for product code OIZ 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...". FDA records list one 510(k) clearance for Visual Footcare Technologies, LLC. As of , FDA records show no recalls naming K080816.

Clearance record

Decision date
Received
(92 days to decision)
Product code
OIZ Foot Examination Tool For Inflammatory Changes
Regulation
21 CFR 890.5050
Device class
Class I
Review panel
Physical Medicine
Applicant
Visual Footcare Technologies, LLC P.O. Box 760, South Salem NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIZ

Trailing 12 months

FDA records hold no clearances under product code OIZ in the trailing twelve months.

FDA records show no clearances under product code OIZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OIZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260