510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760441Substantially Equivalent

Body Warmer (Shake-N-Warm)

Yamada Co., Ltd of Japan, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760441 is the FDA 510(k) clearance record for BODY WARMER (SHAKE-N-WARM), a class I device, cleared for Yamada Co., Ltd of Japan on under FDA product code IMD (Pack, Hot Or Cold, Disposable). FDA records list one 510(k) clearance for Yamada Co., Ltd of Japan. As of , FDA records show no recalls naming K760441.

Clearance record

Decision date
Received
(31 days to decision)
Product code
IMD Pack, Hot Or Cold, Disposable
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Applicant
Yamada Co., Ltd of Japan 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IMD

Trailing 12 months

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

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