ClearanceBrief
Panels › Physical Medicine › Product code ILO · Class 2

Pack, Hot Or Cold, Water Circulating

Regulation 890.5720

0510(k)s in 12 months (93 all time)
4recalls in 12 months (22 all time)
4recalls that name a 510(k)
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Top companies in ILO

DateFirm and productCodeLinked 510(k)
May 8, 2026DJO, LLC
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3 cold therapy
Open, Classified
ILONone listed
May 8, 2026DJO, LLC
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3 cold therapy
Open, Classified
ILONone listed
May 8, 2026DJO, LLC
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3 cold therapy
Open, Classified
ILONone listed
May 8, 2026DJO, LLC
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3 cold therapy unit helps r
Open, Classified
ILONone listed
Nov 22, 2021Gentherm Medical, LLC
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Terminated
ILONone listed
Jul 19, 2019Cincinnati Sub-Zero Products LLC, a Gentherm Company
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Terminated
ILONone listed
Mar 14, 2018Stryker Medical Division of Stryker Corporation
T/Pump temperature therapy pump, Models TP700 and TP700C
Terminated
ILOK073675
Feb 19, 2015Cincinnati Sub-Zero Products Inc
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been position
Terminated
ILOK843146
K902269
Jan 27, 2014DeRoyal Industries Inc
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Terminated
ILONone listed
Jan 27, 2014DeRoyal Industries Inc
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Terminated
ILONone listed
Jan 27, 2014DeRoyal Industries Inc
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Terminated
ILONone listed
Jan 27, 2014DeRoyal Industries Inc
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Terminated
ILONone listed
Jan 27, 2014DeRoyal Industries Inc
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Terminated
ILONone listed
Jan 27, 2014DeRoyal Industries Inc
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
Terminated
ILONone listed
Feb 12, 2013Breg Inc
BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
Terminated
ILOK920581
Feb 12, 2013Breg Inc
BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local a
Terminated
ILONone listed
Jun 24, 2011Pro Trainers' Choice Company
Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of
Terminated
ILONone listed
Feb 4, 2010Cincinnati Sub-Zero Products Inc
TempPad Cold Therapy Pad. The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.
Terminated
ILONone listed
Sep 4, 2009Breg Inc, An Orthofix Company
Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold-therapy device. The Power Supply is plugged into a standard electrical wall s
Terminated
ILONone listed
Apr 6, 2005Cincinnati Sub-Zero Products Inc
Micro-temp II heat therapy unit, model #747.
Terminated
ILOK843146
Apr 6, 2005Cincinnati Sub-Zero Products Inc
Electri-Cool II
Terminated
ILONone listed
Mar 9, 2005DeRoyal Technologies Inc
Cold Therapy Blanket
Terminated
ILONone listed

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