ILO · Class II · 21 CFR 890.5720

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

Leading manufacturers include Hollister, Inc., Kinetic Concepts, Inc. and Baxter Healthcare Corp.

93
Total
93
Cleared
132d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Pack, Hot Or Cold, Water Circulating Devices (Product Code ILO)

93 devices
1–24 of 93
Cleared Jun 10, 2022
Armory Motion
K213097
Pain Management Technologies, Inc.
Neurology · 259d
Cleared Nov 03, 1997
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
K973023
Hollister, Inc.
Physical Medicine · 81d
Cleared Apr 15, 1997
MODEL 1100 COLD THERAPY DEVICE
K970533
Smith & Nephew, Inc.
Physical Medicine · 62d
Cleared Dec 31, 1996
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
K964006
Hollister, Inc.
Physical Medicine · 85d
Cleared Dec 31, 1996
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
K964057
Hollister, Inc.
Physical Medicine · 83d
Cleared Nov 27, 1996
INCARE HOT/ICE LITE MACHINE
K962537
Hollister, Inc.
Physical Medicine · 152d
Cleared Aug 18, 1995
THERMOCOOL SYSTEM
K950395
Zimmer, Inc.
Physical Medicine · 198d
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 Dec 02, 1976
TECNOL PATIENT USE ICE PACK
K760782
Tecnol New Jersey Wound Care, Inc.
Physical Medicine · 58d

About Product Code ILO - Regulatory Context

510(k) Submission Activity

93 total 510(k) submissions under product code ILO since 1976, with 93 receiving FDA clearance (average review time: 132 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.