510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803177Substantially Equivalent

Moist Heat Pack

Duro-Med Ind., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803177 is the FDA 510(k) clearance record for MOIST HEAT PACK, a class I device, cleared for Duro-Med Ind., Inc. on under FDA product code IMA (Pack, Heat, Moist). FDA records list 2 510(k) clearances for Duro-Med Ind., Inc., from to . As of , FDA records show no recalls naming K803177.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IMA Pack, Heat, Moist
Regulation
21 CFR 890.5730
Device class
Class I
Review panel
Physical Medicine
Applicant
Duro-Med Ind., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IMA

Trailing 12 months

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

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