Thermogard HQ Temperature Management System, Thermogard XP Temperature Management System (VitalTemp Universal Pad)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- VitalTemp Universal Pad EUDAMED
- Model / Reference
- 8700-001131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849111076289 EUDAMED
- Basic UDI-DI
- 08491110AH7F EUDAMED
- 510(k) Number
- K250979 FDA 510(k)
- FDA Product Code
- NZE FDA 510(k)
- EMDN Code
- M040799 SPECIAL PADS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5900 FDA 510(k)
- Regulation Number
- 870.5900 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Thermogard HQ and Thermogard XP Temperature Management Systems are active cooling devices designed for hypothermia therapy and temperature regulation in patients. Classified as hyperthermia monitors under the FDA’s device nomenclature, they employ conductive and convective cooling to maintain precise body temperature control, particularly in critical care settings such as post-cardiac arrest or neurosurgical recovery.
These systems are supplied as reusable medical devices, featuring single-use disposable pads (VitalTemp Universal Pad) for patient contact. They are intended for use in hospital intensive care units and emergency departments, with compliance to FDA 510(k) clearance and EU MDR regulations. The devices operate within Class II risk classification and require proper calibration, storage in a clean environment, and adherence to manufacturer instructions for safe, repeated use.
Frequently asked questions
Are the Thermogard HQ and Thermogard XP systems reusable or single-use devices, and how does that affect their use in clinical settings?
The Thermogard HQ and Thermogard XP Temperature Management Systems themselves are reusable medical devices, designed for repeated use in hospital settings like intensive care units and emergency departments. However, they require single-use disposable pads (VitalTemp Universal Pad) for direct patient contact, ensuring hygiene and reducing cross-contamination risks. This setup allows clinicians to maintain device functionality while adhering to infection control protocols.
What types of clinical environments are these temperature management systems intended for, and why?
These systems are specifically designed for critical care settings, such as post-cardiac arrest recovery or neurosurgical recovery, where precise temperature regulation is critical. The active cooling technology (conductive and convective) helps manage hypothermia therapy, which is often required in these high-risk scenarios to stabilize patients and improve outcomes. Their use in ICUs and emergency departments aligns with the need for reliable temperature control in acute, life-threatening conditions.
How should the reusable components of the Thermogard systems be stored and maintained to ensure proper function and safety?
The reusable parts of the Thermogard HQ and XP systems must be stored in a clean environment and undergo regular calibration to maintain accuracy and performance. The manufacturer’s instructions should be followed strictly, including proper cleaning and disinfection protocols between uses. This ensures the devices remain effective for temperature regulation while minimizing the risk of contamination or malfunctions in clinical settings.
What distinguishes the Thermogard XP from the Thermogard HQ in terms of functionality or intended use?
While both systems are active cooling devices for hypothermia therapy and temperature regulation, the distinction lies in their specific design iterations or performance enhancements (not explicitly detailed in the provided data). Both are classified under the FDA’s hyperthermia monitor category and share the same reusable design with single-use pads, suggesting they may differ in features like cooling precision, user interface, or compatibility with certain patient monitoring systems—though the exact differences would require consulting the manufacturer’s technical specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250979 | Class II | Active |
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Manufacturer
- Manufacturer
- ZOLL Circulation, Inc.
Sources (2)
- FDA 510(k) K250979 24 fields · synced Sep 18, 2026
- EUDAMED 917a3bee-56af-4414-845f-20d93262677c 61 fields · synced Jul 26, 2026