510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964354Substantially Equivalent

Artocool-S Water Circulating Cold Pack

Ormed GmbH, Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964354 is the FDA 510(k) clearance record for ARTOCOOL-S WATER CIRCULATING COLD PACK, a class II device, cleared for Ormed GmbH on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 2 510(k) clearances for Ormed GmbH. As of , FDA records show no recalls naming K964354.

Clearance record

Decision date
Received
(302 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Ormed GmbH 1000 Burnette Ave., Suite 450, Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code ILO

Trailing 12 months

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

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