IMA · Class I · 21 CFR 890.5730

FDA Product Code IMA: Pack, Heat, Moist

Leading manufacturers include Rachel'S Remedies, LLC, Fred Sammons, Inc. and Maddak, Inc..

8
Total
8
Cleared
35d
Avg days
1979
Since

FDA 510(k) Cleared Pack, Heat, Moist Devices (Product Code IMA)

8 devices
1–8 of 8
Cleared May 22, 2015
Rachel's Remedy
K150139
Rachel'S Remedies, LLC
Physical Medicine · 120d
Cleared May 10, 1984
HEAT PACK
K841698
Maddak, Inc.
Physical Medicine · 17d
Cleared Dec 30, 1982
INSULATED THERMOELASTOMER MITT
K823622
Fred Sammons, Inc.
Physical Medicine · 24d

About Product Code IMA - Regulatory Context