510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801625Substantially Equivalent

Thermolator Heating Unit

Tru-Eze Mfg. Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801625 is the FDA 510(k) clearance record for THERMOLATOR HEATING UNIT, a class I device, cleared for Tru-Eze Mfg. Co., Inc. on under FDA product code IRQ (Unit, Heating, Powered). FDA records list 3 510(k) clearances for Tru-Eze Mfg. Co., Inc., from to . As of , FDA records show no recalls naming K801625.

Clearance record

Decision date
Received
(13 days to decision)
Product code
IRQ Unit, Heating, Powered
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Applicant
Tru-Eze Mfg. Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IRQ

Trailing 12 months

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

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