ILO · Class II · 21 CFR 890.5720

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

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

93
Total
93
Cleared
132d
Avg days
1976
Since
93 devices
73–93 of 93
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 30, 1988
DAS SPORT PUMP(TM)
K883681
D.A. Schulman, Inc.
Physical Medicine · 32d
Cleared Sep 23, 1988
DUAL-TEMP(TM) COOLING/WARMING UNIT
K882310
Seabrook Medical Systems, Inc.
Physical Medicine · 112d
Cleared Jun 26, 1987
HOT/ICE DUAL FUNCTION EQUIPMENT
K871962
Thermo Temp, Inc.
Physical Medicine · 37d
Cleared Jun 26, 1987
HOT/ICE DISPOSABLE BLANKET
K871963
Thermo Temp, Inc.
Physical Medicine · 37d
Cleared Sep 05, 1985
CAST-TECH CO. COOLING SYSTEM
K852495
Cast-Tech Co.
Physical Medicine · 85d
Cleared Aug 17, 1984
MICRO-TEMP PUMPS & MICRO-TEMP PADS
K843146
Seabrook Medical Systems, Inc.
Physical Medicine · 7d
Cleared Nov 28, 1983
HOT/ICE DISPOSABLE BLANKET
K833564
Thermo Temp, Inc.
Physical Medicine · 47d
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 Mar 29, 1983
HOT/ICE
K830757
Thermo Temp, Inc.
Physical Medicine · 19d
Cleared Jun 20, 1980
GOLDEN THERMAL RHINOPLASTY CAST BANDAGE
K801301
Auric, Inc.
Physical Medicine · 17d
Cleared Sep 04, 1979
GELSKIN
K791162
Spenco Medical Corp.
Physical Medicine · 71d
Cleared Jun 21, 1978
THERA-PAK
K780452
Hydro-Med Products, Inc.
Physical Medicine · 92d
Cleared Feb 24, 1977
BAND-AGE ICE-BANDAGE
K761254
Surgicot, Inc.
Physical Medicine · 73d
Cleared Dec 16, 1976
DISPOSABLE K-PADS
K760910
Gorman Rupp Industries
Physical Medicine · 50d
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