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
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 Jun 10, 2009
COOLSKIN
K083008
Elbio Co., Ltd.
Physical Medicine · 245d
Cleared May 08, 2008
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
K073675
Gaymar Industries, Inc.
Physical Medicine · 132d
Cleared Sep 07, 2007
JUNIPER CLN1 DERMAL COOLING DEVICE
K072152
Juniper Medical, Inc.
Physical Medicine · 35d
Cleared Mar 29, 2007
MODIFICATION TO POLAR CARE 500
K070402
Breg, Inc.
Physical Medicine · 45d
Cleared May 07, 2004
IVC SYSTEM
K040317
Mark H. Friedman
Physical Medicine · 88d
Cleared Nov 03, 1997
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
K973023
Hollister, Inc.
Physical Medicine · 81d
Cleared Sep 10, 1997
HTP-1500 LOCALIZED HEAT THERAPY PUMP
K970197
Adroit Medical Systems, Inc.
Physical Medicine · 232d
Cleared Aug 29, 1997
ARTOCOOL-S WATER CIRCULATING COLD PACK
K964354
Ormed GmbH
Physical Medicine · 302d
Cleared Aug 29, 1997
ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
K964799
Ormed GmbH
Physical Medicine · 273d
Cleared May 09, 1997
BLEDSOE COLD CONTROL
K964710
Med Technology, Inc.
Physical Medicine · 165d
Cleared Apr 15, 1997
MODEL 1100 COLD THERAPY DEVICE
K970533
Smith & Nephew, Inc.
Physical Medicine · 62d
Cleared Jan 10, 1997
STERILE SOFT-TEMP
K962983
Adroit Medical Systems, Inc.
Physical Medicine · 162d
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 Dec 04, 1996
POLAR CARE 300
K963596
Breg, Inc.
Physical Medicine · 86d
Cleared Nov 27, 1996
INCARE HOT/ICE LITE MACHINE
K962537
Hollister, Inc.
Physical Medicine · 152d
Cleared Oct 31, 1996
THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
K961621
Therapy Concepts, Inc.
Physical Medicine · 188d
Cleared Oct 28, 1996
BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
K961425
Bio Compression Systems, Inc.
Physical Medicine · 199d
Cleared Sep 27, 1996
EBI THERMAL THERAPY SYSTEM
K963261
Electro-Biology, Inc.
Physical Medicine · 38d
Cleared Aug 09, 1996
POLAR CARE (MODEL 500/50000)
K961855
Breg, Inc.
Physical Medicine · 87d
Cleared Jun 10, 1996
CRYTRON SYSTEM
K955529
Mark H. Friedman
Physical Medicine · 189d
Cleared Apr 10, 1996
SPORTS CONTRAST THERAPY SYSTEM ST 7000
K955326
Burke Neutech, Inc.
Physical Medicine · 142d
Cleared Mar 08, 1996
MODEL 1100 COLD THERAPY DEVICE
K955057
Smith and Nephew Donjoy, Inc.
Physical Medicine · 123d

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.