Home › Manamed, Inc. › ManaMed
ManaMed
Manamed, Inc. · Model ManaCold · UDI-DI 00850998008980
ILO
Prescription
10
510(k) clearances
984
Adverse events (3 deaths)
22
Recalls
125
Facilities
Description
ManaCold Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad. Commonly used following knee surgery, shoulder surgery or back surgery ManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting
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 normothermia maintenanc |
| 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 and controlling it t |
| 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 and controlling it t |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.