510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841698Substantially Equivalent

Heat Pack

Maddak, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841698 is the FDA 510(k) clearance record for HEAT PACK, a class I device, cleared for Maddak, Inc. on under FDA product code IMA (Pack, Heat, Moist). FDA records list 51 510(k) clearances for Maddak, Inc., from to . As of , FDA records show no recalls naming K841698.

Clearance record

Decision date
Received
(17 days to decision)
Product code
IMA Pack, Heat, Moist
Regulation
21 CFR 890.5730
Device class
Class I
Review panel
Physical Medicine
Applicant
Maddak, Inc. 4221 Richmond Rd., NW, Walker MI
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