510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142228Substantially Equivalent

Heated Eye Pad

Digital Heat Corporation, Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K142228 is the FDA 510(k) clearance record for Heated Eye Pad, a class II device, cleared for Digital Heat Corporation on under FDA product code IRT (Pad, Heating, Powered). FDA records list one 510(k) clearance for Digital Heat Corporation. As of , FDA records show no recalls naming K142228.

Clearance record

Decision date
Received
(180 days to decision)
Product code
IRT Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
Digital Heat Corporation 5626 S. Captain Kidd Ct. Unit B, Tempe AZ
510(k) summary
Statement
Third party review
No

Clearances, product code IRT

Trailing 12 months

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

FDA records show no clearances under product code IRT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IRT, 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