ILO · Class II · 21 CFR 890.5720

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

Leading manufacturers include Hollister, Inc., Seabrook Medical Systems, Inc. and Breg, Inc..

93
Total
93
Cleared
132d
Avg days
1976
Since
93 devices
25–48 of 93
Cleared Mar 06, 1996
MEDICOOL (MODIFICATON)
K954095
Microclimate Systems, Inc.
Physical Medicine · 199d
Cleared Oct 05, 1995
THERMOTEK H-300
K945853
Thermotek, Inc.
Physical Medicine · 339d
Cleared Oct 04, 1995
EBICE
K953532
Electro-Biology, Inc.
Physical Medicine · 69d
Cleared Aug 18, 1995
THERMOCOOL SYSTEM
K950395
Zimmer, Inc.
Physical Medicine · 198d
Cleared Jul 06, 1995
T-350 THERAPEUTIC COOLING MACHINE
K950711
Thermotek, Inc.
Physical Medicine · 142d
Cleared Jun 19, 1995
T-300 COOLER
K945468
Temptek, Inc.
Physical Medicine · 223d
Cleared Jun 07, 1995
CONTRAST 7000 THERAPY SYSTEM
K943497
Burke Neutech, Inc.
Physical Medicine · 323d
Cleared Apr 28, 1995
BABYTHERM 8000 WB
K945467
Drager, Inc.
Physical Medicine · 172d
Cleared Apr 18, 1995
HPRH HOSPITAL PATIENT RADIANT HEATER
K934262
Marley Electric Heating Co.
Physical Medicine · 595d
Cleared Mar 07, 1995
DELTA THERM COLD THERAPY SYSTEM
K945399
Deltatherm
Physical Medicine · 123d
Cleared Feb 09, 1995
TOTALLY COOL(TM) TC-2
K942882
Electro Science Technologies, Inc.
Physical Medicine · 237d
Cleared Feb 09, 1995
TOTALLY COOL(TM) TC-1
K943844
Electro Science Technologies, Inc.
Physical Medicine · 237d
Cleared Feb 09, 1995
COOL/HEAT THERAPY APPLICATOR
K944447
Medical Science Technology, Inc.
Physical Medicine · 150d
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 Aug 29, 1994
DR KOOL
K935841
Toronto Medical Corp.
Physical Medicine · 265d
Cleared Jul 12, 1994
ISOCOMFORTER
K936143
Isocomforter, Inc.
Physical Medicine · 197d
Cleared Jul 12, 1994
ORTHO TECH CRYOLOGIC SYSTEM
K940429
Orthopedic Technology, Inc.
Physical Medicine · 162d
Cleared Jul 12, 1994
THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)
K940858
Innovation Sports, Inc.
Physical Medicine · 139d
Cleared May 27, 1994
TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
K940160
Burke Neutech, Inc.
Physical Medicine · 135d
Cleared May 25, 1994
HYDROT
K930918
Sanker Intl., Inc.
Physical Medicine · 462d
Cleared Feb 22, 1994
COOL-AID
K931203
Seabrook Medical Systems, Inc.
Physical Medicine · 350d
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