Home › Device types › ILO
Pack, Hot Or Cold, Water Circulating
FDA product code ILO · Class 2 · Physical Medicine
1,278
Registered devices
984
Adverse events
22
Recalls
93
510(k) clearances
Devices with this code
ThermoTek WRAP, KNEE,STD, HL, SPU, UF — THERMOTEK, INC.Therm-X — ZENITH TECHNICAL INNOVATIONS, LLCWalgreens — WALGREEN CO.Hyperice / NormaTec — NORMATEC INDUSTRIES LPGame Ready Ankle Heat Exchanger - Large- Rental — Avanos Medical, Inc.Soft-Temp — ADROIT MEDICAL SYSTEMS, INC.Soft-Temp — ADROIT MEDICAL SYSTEMS, INC.BREG — BREG, INC.Medichoice — OWENS & MINOR DISTRIBUTION, INC.CRYOPUSH — Chengdu Cryo-push Medical Technology Co.,Ltd.Game Ready — Avanos Medical, Inc.Mul-T-Pad — STRYKER CORPORATIONTherm-X — ZENITH TECHNICAL INNOVATIONS, LLCPremierPro — PRESTIGE AMERITECH, LTD.BREG — BREG, INC.T/Pad — STRYKER CORPORATIONGame Ready — Avanos Medical, Inc.BREG — BREG, INC.BREG — BREG, INC.Therm-X — ZENITH TECHNICAL INNOVATIONS, LLCDONJOY — DJO, LLCThermoTek Inc Foot/Ankle Wrap-Carton — THERMOTEK, INC.Game Ready — Avanos Medical, Inc.BREG — BREG, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | DJO, LLC | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 2026-03-19 | DJO, LLC | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 2026-03-19 | DJO, LLC | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 2026-03-19 | DJO, LLC | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 2021-11-22 | Gentherm Medical, LLC | This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. |
| 2019-07-19 | Cincinnati Sub-Zero Products LLC, a Gentherm Company | Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage |
| 2017-11-07 | Stryker Medical Division of Stryker Corporation | The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for nor |
| 2015-01-07 | Cincinnati Sub-Zero Products Inc | Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. |
| 2013-09-17 | DeRoyal Industries Inc | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended |
| 2013-09-17 | DeRoyal Industries Inc | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended |
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