Pack, Hot Or Cold, Water Circulating
FDA product code ILO · Class II (moderate risk) · 21 CFR 890.5720 · Physical Medicine
93510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Hollister, Inc. 7
- Breg, Inc. 6
- Seabrook Medical Systems, Inc. 6
- Gaymar Industries, Inc. 5
- Burke Neutech, Inc. 4
- Thermo Temp, Inc. 4
- Electro-Biology, Inc. 3
- Temptek, Inc. 3
- Ormed GmbH 2
- Baxter Healthcare Corp 2
- Life Enhancement Technologies, LLC 2
- Burke, Inc. 2
- Ati 2
- Kinetic Concepts, Inc. 2
- Electro Science Technologies, Inc. 2
- Thermotek, Inc. 2
- Adroit Medical Systems, Inc. 2
- Mark H. Friedman 2
- Pain Management Technologies 1
- Hydro-Med Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213097 | Armory MotionILO · Traditional | Pain Management Technologies, Inc. | 06/10/2022SE |
| K083008 | CoolskinILO · Abbreviated | Elbio Co., Ltd. | 06/10/2009SE |
| K073675 | T-Pump Localized Temperature Therapy PumpILO · Traditional | Gaymar Industries, Inc. | 05/08/2008SE |
| K072152 | Juniper CLN1 Dermal Cooling DeviceILO · Traditional | Juniper Medical, Inc. | 09/07/2007SE |
| K070402 | Modification to Polar Care 500ILO · Special | Breg, Inc. | 03/29/2007SE |
| K040317 | Ivc SystemILO · Traditional | Mark H. Friedman | 05/07/2004SE |
| K973023 | Incare Hot/Ice System Foot/Ankle BlanketILO · Traditional | Hollister, Inc. | 11/03/1997SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | Adroit Medical Systems, Inc. | 09/10/1997SE |
| K964799 | Artrotherm Cryotherapy and ThernotherapyILO · Traditional | Ormed GmbH | 08/29/1997SE |
| K964354 | Artocool-S Water Circulating Cold PackILO · Traditional | Ormed GmbH | 08/29/1997SE |
| K964710 | Bledsoe Cold ControlILO · Traditional | Med Technology, Inc. | 05/09/1997SE |
| K970533 | Model 1100 Cold Therapy DeviceILO · Traditional | Smith & Nephew, Inc. | 04/15/1997SE |
| K962983 | Sterile Soft-TempILO · Traditional | Adroit Medical Systems, Inc. | 01/10/1997SE |
| K964057 | Incare Hot/Ice System Shoulder BlanketILO · Traditional | Hollister, Inc. | 12/31/1996SE |
| K964006 | Incare Hot/Ice System Blankets (Various Sizes and Shapes)ILO · Traditional | Hollister, Inc. | 12/31/1996SE |
| K963596 | Polar Care 300ILO · Traditional | Breg, Inc. | 12/04/1996SE |
| K962537 | Incare Hot/Ice Lite MachineILO · Traditional | Hollister, Inc. | 11/27/1996SE |
| K961621 | Therapy Concepts Water Circulating Treatment SystemILO · Traditional | Therapy Concepts, Inc. | 10/31/1996SE |
| K961425 | Bio Compression Cold Flo, Single Chamber Intermittent and Multi-Chamber Sequential ModelsILO · Traditional | Bio Compression Systems, Inc. | 10/28/1996SE |
| K963261 | Ebi Thermal Therapy SystemILO · Traditional | Electro-Biology, Inc. | 09/27/1996SE |
| K961855 | Polar Care (Model 500/50000)ILO · Traditional | Breg, Inc. | 08/09/1996SE |
| K955529 | Crytron SystemILO · Traditional | Mark H. Friedman | 06/10/1996SE |
| K955326 | Sports Contrast Therapy System ST 7000ILO · Traditional | Burke Neutech, Inc. | 04/10/1996SN |
| K955057 | Model 1100 Cold Therapy DeviceILO · Traditional | Smith and Nephew Donjoy, Inc. | 03/08/1996SN |
| K954095 | Medicool (Modificaton)ILO · Traditional | Microclimate Systems, Inc. | 03/06/1996SN |
| K945853 | Thermotek H-300ILO · Traditional | Thermotek, Inc. | 10/05/1995SN |
| K953532 | EbiceILO · Traditional | Electro-Biology, Inc. | 10/04/1995SE |
| K950395 | Thermocool SystemILO · Traditional | Zimmer, Inc. | 08/18/1995SN |
| K950711 | T-350 Therapeutic Cooling MachineILO · Traditional | Thermotek, Inc. | 07/06/1995SE |
| K945468 | T-300 CoolerILO · Traditional | Temptek, Inc. | 06/19/1995SE |
| K943497 | Contrast 7000 Therapy SystemILO · Traditional | Burke Neutech, Inc. | 06/07/1995SE |
| K945467 | Babytherm 8000 WBILO · Traditional | Drager, Inc. | 04/28/1995SE |
| K934262 | HPRH Hospital Patient Radiant HeaterILO · Traditional | Marley Electric Heating Co. | 04/18/1995SN |
| K945399 | Delta Therm Cold Therapy SystemILO · Traditional | Deltatherm | 03/07/1995SN |
| K945067 | EbiceILO · Traditional | Electro-Biology, Inc. | 02/09/1995SN |
| K944447 | Cool/Heat Therapy ApplicatorILO · Traditional | Medical Science Technology, Inc. | 02/09/1995SN |
| K943844 | Totally Cool(Tm) TC-1ILO · Traditional | Electro Science Technologies, Inc. | 02/09/1995SN |
| K942882 | Totally Cool(Tm) TC-2ILO · Traditional | Electro Science Technologies, Inc. | 02/09/1995SN |
| K944971 | Incare Hot/Ice Cold Therapy CoolerILO · Traditional | Hollister, Inc. | 01/30/1995SN |
| K935841 | DR KoolILO · Traditional | Toronto Medical Corp. | 08/29/1994SN |
| K940858 | Thera Cool Home Unit/Coolpac(Ambu/Reservior Units)ILO · Traditional | Innovation Sports, Inc. | 07/12/1994SN |
| K940429 | Ortho Tech Cryologic SystemILO · Traditional | Orthopedic Technology, Inc. | 07/12/1994SN |
| K936143 | IsocomforterILO · Traditional | Isocomforter, Inc. | 07/12/1994SN |
| K940160 | TS1000 Portable Disposable Cold Therapy SystemILO · Traditional | Burke Neutech, Inc. | 05/27/1994SE |
| K930918 | HydrotILO · Traditional | Sanker Intl., Inc. | 05/25/1994SE |
| K931203 | Cool-AidILO · Traditional | Seabrook Medical Systems, Inc. | 02/22/1994SE |
| K931843 | Hot/Ice System Sterile Conformable/Disp. BlanketsILO · Traditional | Hollister, Inc. | 02/02/1994SE |
| K930634 | Sur Flo Thermal Therapy PadsILO · Traditional | Buckman Co., Inc. | 11/01/1993SE |
| K926151 | LSI6000 Thermal Therapy SystemILO · Traditional | Burke Neutech, Inc. | 05/26/1993SE |
| K925677 | Autochill Accessory KitILO · Traditional | Aircast, Inc. | 04/14/1993SE |
| K923643 | MedicoolILO · Traditional | Micromedic Systems | 03/31/1993SE |
| K921540 | Cooling/Heating Therapy DeviceILO · Traditional | Tempacure Home Care | 07/21/1992SE |
| K920581 | Polar Pad (Sterile)ILO · Traditional | Breg, Inc. | 03/20/1992SE |
| K915196 | Incare Hot/Ice System 3ILO · Traditional | Hollister, Inc. | 02/03/1992SE |
| K913026 | TTU-100THERMAL Therapy UnitILO · Traditional | Danninger Medical Technology, Inc. | 12/13/1991SE |
| K914434 | Polar PadsILO · Traditional | Breg, Inc. | 10/24/1991SE |
| K914182 | Golden Thermal(R)ILO · Traditional | Seabrook Medical Systems, Inc. | 10/18/1991SE |
| K913729 | Polar Pump, Model 500ILO · Traditional | Breg, Inc. | 10/18/1991SE |
| K912722 | Hyper-K Heat SystemILO · Traditional | Baxter Healthcare Corp | 09/11/1991SE |
| K911943 | Concept Model 5200 Thermal Therapy SystemILO · Traditional | Burke, Inc. | 07/19/1991SE |
| K910061 | K-Module II Heat Therapy SystemILO · Traditional | Baxter Healthcare Corp | 02/13/1991SE |
| K904998 | The Body Cooler SystemILO · Traditional | Costa / French | 01/14/1991SE |
| K902269 | Electri-Cool(Tm) Liquid-Circulat. Thermal TherapyILO · Traditional | Seabrook Medical Systems, Inc. | 06/21/1990SE |
| K902268 | Pedia-Temp(Tm) Liquid-Circulating Hypo-Hypertherm.ILO · Traditional | Seabrook Medical Systems, Inc. | 06/21/1990SE |
| K900356 | Thermoaire Splint (TM) (Tas)ILO · Traditional | Life Enhancement Technologies, LLC | 05/07/1990SE |
| K891091 | Temptek T-1000 Therapeutic Cooling UnitILO · Traditional | Temptek, Inc. | 03/26/1990SE |
| K900355 | Mark Vii Thermoregulation Assist SystemILO · Traditional | Life Enhancement Technologies, LLC | 02/15/1990SE |
| K891603 | Body Cooler or Coolvest or Alpha Body CoolerILO · Traditional | Alpha Rehabilitation Products | 07/25/1989SE |
| K893706 | Cold/Hot Fluid Radiation Pad NeutechILO · Traditional | Burke, Inc. | 06/22/1989SE |
| K891092 | Temptek 5010 Thermal Cooling BlanketILO · Traditional | Temptek, Inc. | 05/26/1989SE |
| K890853 | Aqua-Pad for Moist or Dry Heat TherapyILO · Traditional | Ati | 04/14/1989SE |
| K890852 | Aqua-Blanket Hyper/Hypohermia BlanketILO · Traditional | Ati | 04/14/1989SE |
| K891151 | Cool 'N Heat MachineILO · Traditional | Kinetic Concepts, Inc. | 04/06/1989SE |
| K891152 | Grand Cooling MachineILO · Traditional | Kinetic Concepts, Inc. | 03/23/1989SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | Concept, Inc. | 11/08/1988SE |
| K883681 | Das Sport Pump(Tm)ILO · Traditional | D.A. Schulman, Inc. | 09/30/1988SE |
| K882310 | Dual-Temp(Tm) Cooling/Warming UnitILO · Traditional | Seabrook Medical Systems, Inc. | 09/23/1988SE |
| K871963 | Hot/Ice Disposable BlanketILO · Traditional | Thermo Temp, Inc. | 06/26/1987SE |
| K871962 | Hot/Ice Dual Function EquipmentILO · Traditional | Thermo Temp, Inc. | 06/26/1987SE |
| K852495 | Cast-Tech Co. Cooling SystemILO · Traditional | Cast-Tech Co. | 09/05/1985SE |
| K843146 | Micro-Temp Pumps & Micro-Temp PadsILO · Traditional | Seabrook Medical Systems, Inc. | 08/17/1984SE |
| K833564 | Hot/Ice Disposable BlanketILO · Traditional | Thermo Temp, Inc. | 11/28/1983SE |
| K832820 | Mul-T-BlanketILO · Traditional | Gaymar Industries, Inc. | 09/26/1983SE |
| K832819 | Mul-T-PadILO · Traditional | Gaymar Industries, Inc. | 09/26/1983SE |
| K830757 | Hot/IceILO · Traditional | Thermo Temp, Inc. | 03/29/1983SE |
| K801301 | Golden Thermal Rhinoplasty Cast BandageILO · Traditional | Auric, Inc. | 06/20/1980SE |
| K791162 | GelskinILO · Traditional | Spenco Medical Corp. | 09/04/1979SE |
| K780452 | Thera-PakILO · Traditional | Hydro-Med Products, Inc. | 06/21/1978SE |
| K761254 | Band-Age Ice-BandageILO · Traditional | Surgicot, Inc. | 02/24/1977SE |
| K760910 | Disposable K-PadsILO · Traditional | Gorman Rupp Industries | 12/16/1976SE |
| K760782 | Tecnol Patient Use Ice PackILO · Traditional | Tecnol New Jersey Wound Care, Inc. | 12/02/1976SE |
| K760804 | T-Pump, Temperature - Therapy PumpILO · Traditional | Gaymar Industries, Inc. | 10/15/1976SE |
| K760527 | T-PadILO · Traditional | Gaymar Industries, Inc. | 09/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2137-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Djo, LLC | 03/19/2026Open, Classified |
| Z-2136-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Djo, LLC | 03/19/2026Open, Classified |
| Z-2135-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Djo, LLC | 03/19/2026Open, Classified |
| Z-2134-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Djo, LLC | 03/19/2026Open, Classified |
| Z-0496-2022 Class II | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193This recall has been initiated to provide a labeling update with revised instruction how to operate the unit… | Gentherm Medical, LLC | 11/22/2021Terminated |
| Z-2291-2019 Class III | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a…Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue… | Cincinnati Sub-Zero Products LLC, a… | 07/19/2019Terminated |
| Z-1013-2018 Class III | T/Pump temperature therapy pump, Models TP700 and TP700CThe T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence… | Stryker Medical Division of Stryker… | 11/07/2017Terminated |
| Z-1129-2015 Class II | Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used…Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water… | Cincinnati Sub-Zero Products Inc | 01/07/2015Terminated |
| Z-0839-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | DeRoyal Industries Inc | 09/17/2013Terminated |
| Z-0838-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | DeRoyal Industries Inc | 09/17/2013Terminated |
| Z-0837-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | DeRoyal Industries Inc | 09/17/2013Terminated |
| Z-0836-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | DeRoyal Industries Inc | 09/17/2013Terminated |
| Z-0835-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | DeRoyal Industries Inc | 09/17/2013Terminated |
| Z-0834-2014 Class II | Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | DeRoyal Industries Inc | 09/17/2013Terminated |
| Z-0804-2013 Class II | BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s:…The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from… | Breg Inc | 01/14/2013Terminated |
| Z-0803-2013 Class II | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U…The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from… | Breg Inc | 01/14/2013Terminated |
| Z-2659-2011 | Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device…The control panel of the Precision Ice One Patient Use Control Unit and Wrap System has a overheating issue.… | Pro Trainers' Choice Company | 04/18/2011Terminated |
| Z-0782-2010 | TempPad Cold Therapy Pad. The device is used for localized temperature therapy including…Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging… | Cincinnati Sub-Zero Products Inc | 11/14/2009Terminated |
| Z-1989-2009 | Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar…Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the… | Breg Inc, An Orthofix Company | 06/18/2009Terminated |