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
49–72 of 93
Cleared May 26, 1993
LSI6000 THERMAL THERAPY SYSTEM
K926151
Burke Neutech, Inc.
Physical Medicine · 170d
Cleared Apr 14, 1993
AUTOCHILL ACCESSORY KIT
K925677
Aircast, Inc.
Physical Medicine · 272d
Cleared Mar 31, 1993
MEDICOOL
K923643
Micromedic Systems
Physical Medicine · 253d
Cleared Jul 21, 1992
COOLING/HEATING THERAPY DEVICE
K921540
Tempacure Home Care
Physical Medicine · 111d
Cleared Mar 20, 1992
POLAR PAD (STERILE)
K920581
Breg, Inc.
Physical Medicine · 39d
Cleared Feb 03, 1992
INCARE HOT/ICE SYSTEM 3
K915196
Hollister, Inc.
Physical Medicine · 76d
Cleared Dec 13, 1991
TTU-100THERMAL THERAPY UNIT
K913026
Danninger Medical Technology, Inc.
Physical Medicine · 157d
Cleared Oct 24, 1991
POLAR PADS
K914434
Breg, Inc.
Physical Medicine · 20d
Cleared Oct 18, 1991
POLAR PUMP, MODEL 500
K913729
Breg, Inc.
Physical Medicine · 59d
Cleared Oct 18, 1991
GOLDEN THERMAL(R)
K914182
Seabrook Medical Systems, Inc.
Physical Medicine · 30d
Cleared Sep 11, 1991
HYPER-K HEAT SYSTEM
K912722
Baxter Healthcare Corp
Physical Medicine · 85d
Cleared Jul 19, 1991
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
K911943
Burke, Inc.
Physical Medicine · 79d
Cleared Feb 13, 1991
K-MODULE II HEAT THERAPY SYSTEM
K910061
Baxter Healthcare Corp
Physical Medicine · 35d
Cleared Jan 14, 1991
THE BODY COOLER SYSTEM
K904998
Costa / French
Physical Medicine · 69d
Cleared Jun 21, 1990
PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
K902268
Seabrook Medical Systems, Inc.
Physical Medicine · 31d
Cleared Jun 21, 1990
ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
K902269
Seabrook Medical Systems, Inc.
Physical Medicine · 31d
Cleared May 07, 1990
THERMOAIRE SPLINT (TM) (TAS)
K900356
Life Enhancement Technologies, LLC
Physical Medicine · 102d
Cleared Mar 26, 1990
TEMPTEK T-1000 THERAPEUTIC COOLING UNIT
K891091
Temptek, Inc.
Physical Medicine · 389d
Cleared Feb 15, 1990
MARK VII THERMOREGULATION ASSIST SYSTEM
K900355
Life Enhancement Technologies, LLC
Physical Medicine · 21d
Cleared Jul 25, 1989
BODY COOLER OR COOLVEST OR ALPHA BODY COOLER
K891603
Alpha Rehabilitation Products
Physical Medicine · 127d
Cleared Jun 22, 1989
COLD/HOT FLUID RADIATION PAD NEUTECH
K893706
Burke, Inc.
Physical Medicine · 35d
Cleared May 26, 1989
TEMPTEK 5010 THERMAL COOLING BLANKET
K891092
Temptek, Inc.
Physical Medicine · 85d
Cleared Apr 14, 1989
AQUA-BLANKET HYPER/HYPOHERMIA BLANKET
K890852
Ati
Physical Medicine · 52d
Cleared Apr 14, 1989
AQUA-PAD FOR MOIST OR DRY HEAT THERAPY
K890853
Ati
Physical Medicine · 52d