ILO · Class II · 21 CFR 890.5720

FDA Product Code ILO: Pack, Hot Or Cold, Water Circulating

Leading manufacturers include Hollister, Inc., Gaymar Industries, Inc. and Electro-Biology, Inc..

93
Total
93
Cleared
132d
Avg days
1976
Since
93 devices
25–48 of 93
Cleared Apr 28, 1995
BABYTHERM 8000 WB
K945467
Drager, Inc.
Physical Medicine · 172d
Cleared Feb 09, 1995
EBICE
K945067
Electro-Biology, Inc.
Physical Medicine · 118d
Cleared Jan 30, 1995
INCARE HOT/ICE COLD THERAPY COOLER
K944971
Hollister, Inc.
Physical Medicine · 111d
Cleared Feb 02, 1994
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843
Hollister, Inc.
Physical Medicine · 295d
Cleared Nov 01, 1993
SUR FLO THERMAL THERAPY PADS
K930634
Buckman Co., Inc.
Physical Medicine · 266d
Cleared Mar 31, 1993
MEDICOOL
K923643
Micromedic Systems
Physical Medicine · 253d
Cleared Feb 03, 1992
INCARE HOT/ICE SYSTEM 3
K915196
Hollister, Inc.
Physical Medicine · 76d
Cleared Sep 11, 1991
HYPER-K HEAT SYSTEM
K912722
Baxter Healthcare Corp
Physical Medicine · 85d
Cleared Feb 13, 1991
K-MODULE II HEAT THERAPY SYSTEM
K910061
Baxter Healthcare Corp
Physical Medicine · 35d
Cleared Apr 06, 1989
COOL 'N HEAT MACHINE
K891151
Kinetic Concepts, Inc.
Physical Medicine · 34d
Cleared Mar 23, 1989
GRAND COOLING MACHINE
K891152
Kinetic Concepts, Inc.
Physical Medicine · 20d
Cleared Nov 08, 1988
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
K884255
Concept, Inc.
Physical Medicine · 28d
Cleared Sep 26, 1983
MUL-T-PAD
K832819
Gaymar Industries, Inc.
Physical Medicine · 38d
Cleared Sep 26, 1983
MUL-T-BLANKET
K832820
Gaymar Industries, Inc.
Physical Medicine · 38d
Cleared Feb 24, 1977
BAND-AGE ICE-BANDAGE
K761254
Surgicot, Inc.
Physical Medicine · 73d
Cleared Dec 02, 1976
TECNOL PATIENT USE ICE PACK
K760782
Tecnol New Jersey Wound Care, Inc.
Physical Medicine · 58d
Cleared Oct 15, 1976
T-PUMP, TEMPERATURE - THERAPY PUMP
K760804
Gaymar Industries, Inc.
Physical Medicine · 3d
Cleared Sep 03, 1976
T-PAD
K760527
Gaymar Industries, Inc.
Physical Medicine · 7d