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)
Top companies in ILO
| Company | 510(k)s | Recalls |
|---|---|---|
| Breg, Inc. | 6 | 2 |
| Hollister, Inc. | 7 | 0 |
| DeRoyal Industries Inc | 0 | 6 |
| Seabrook Medical Systems, Inc. | 6 | 0 |
| Gaymar Industries, Inc. | 5 | 0 |
| Burke Neutech, Inc. | 4 | 0 |
| Cincinnati Sub-Zero Products Inc | 0 | 4 |
| DJO, LLC | 0 | 4 |
| Thermo Temp, Inc. | 4 | 0 |
| Electro-Biology, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2026 | DJO, 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 |
ILO | None listed |
| May 8, 2026 | DJO, 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 |
ILO | None listed |
| May 8, 2026 | DJO, 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 |
ILO | None listed |
| May 8, 2026 | DJO, 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 |
ILO | None listed |
| Nov 22, 2021 | Gentherm Medical, LLC Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 Terminated |
ILO | None listed |
| Jul 19, 2019 | Cincinnati 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 |
ILO | None listed |
| Mar 14, 2018 | Stryker Medical Division of Stryker Corporation T/Pump temperature therapy pump, Models TP700 and TP700C Terminated |
ILO | K073675 |
| Feb 19, 2015 | Cincinnati 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 |
ILO | K843146 K902269 |
| Jan 27, 2014 | DeRoyal 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 |
ILO | None listed |
| Jan 27, 2014 | DeRoyal 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 |
ILO | None listed |
| Jan 27, 2014 | DeRoyal 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 |
ILO | None listed |
| Jan 27, 2014 | DeRoyal 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 |
ILO | None listed |
| Jan 27, 2014 | DeRoyal 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 |
ILO | None listed |
| Jan 27, 2014 | DeRoyal 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 |
ILO | None listed |
| Feb 12, 2013 | Breg 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 |
ILO | K920581 |
| Feb 12, 2013 | Breg 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 |
ILO | None listed |
| Jun 24, 2011 | Pro 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 |
ILO | None listed |
| Feb 4, 2010 | Cincinnati 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 |
ILO | None listed |
| Sep 4, 2009 | Breg 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 |
ILO | None listed |
| Apr 6, 2005 | Cincinnati Sub-Zero Products Inc Micro-temp II heat therapy unit, model #747. Terminated |
ILO | K843146 |
| Apr 6, 2005 | Cincinnati Sub-Zero Products Inc Electri-Cool II Terminated |
ILO | None listed |
| Mar 9, 2005 | DeRoyal Technologies Inc Cold Therapy Blanket Terminated |
ILO | None listed |
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