IMD · Class I · 21 CFR 890.5710

FDA Product Code IMD: Pack, Hot Or Cold, Disposable

Leading manufacturers include Prism Technologies, Inc., Omni Therm, Inc. and Allegiance Healthcare Corp..

82
Total
82
Cleared
75d
Avg days
1976
Since
82 devices
73–82 of 82
Cleared Sep 04, 1979
KWICK KOOLER
K791675
Stahlex Corp.
Physical Medicine · 7d
Cleared Apr 03, 1979
TULANE HEAT-PACK
K790480
Tulane
Physical Medicine · 26d
Cleared Apr 27, 1978
BODY WARMER
K780426
Q-Matic Corp.
Physical Medicine · 41d
Cleared Apr 21, 1978
COLD PACK
K780603
Abco Dealers, Inc.
Physical Medicine · 11d
Cleared Apr 10, 1978
ICE-PAK, PDI
K780279
Nice-Pak Products, Inc.
Physical Medicine · 48d
Cleared Feb 21, 1978
COLD CYCLE, CHEMICAL COLD PACK
K780014
Signal West
Physical Medicine · 49d
Cleared Nov 07, 1977
KWICK KOOLER
K771660
World Trade Assoc.
Physical Medicine · 69d
Cleared Apr 05, 1977
SHAKE-N-WARM
K770505
Signal West
Physical Medicine · 26d
Cleared Oct 06, 1976
MUL-T-PAD
K760706
Gaymar Industries, Inc.
Physical Medicine · 13d
Cleared Sep 16, 1976
BODY WARMER (SHAKE-N-WARM)
K760441
Yamada Co., Ltd of Japan
Physical Medicine · 31d