Therm-X (Home); Therm-X (AT)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240125 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Therm-X (Home) and Therm-X (AT) are Sleeve, Limb, Compressible devices designed for intermittent or static compression therapy. These devices apply controlled pressure to limbs to manage edema, swelling, and post-surgical recovery, with the AT model additionally incorporating thermal modalities (heat, cold, and contrast therapy).
The Therm-X (Home) and Therm-X (AT) are intended for use in home and clinical settings, respectively, and are classified as Class II devices under FDA regulations (870.5800). Both versions are reusable and feature programmable settings, including password protection for protocol adjustments. The AT model is portable and intended for rehabilitation and sports medicine applications, while the Home version is designed for at-home use. No MRI safety or sterility requirements are specified.
Frequently asked questions
What are the primary clinical applications for the Therm-X devices, and how do they differ between the Home and AT models?
The Therm-X devices are designed for intermittent or static compression therapy to manage edema, swelling, and post-surgical recovery. The Therm-X (Home) is intended for at-home use, while the Therm-X (AT) adds thermal modalities (heat, cold, and contrast therapy) and is optimized for rehabilitation and sports medicine in clinical or portable settings. Both models apply controlled pressure to limbs but the AT model’s thermal features expand its utility for active recovery and inflammation management.
Are the Therm-X devices single-use or reusable, and what maintenance considerations should clinicians or patients keep in mind?
The Therm-X devices are reusable, meaning they are designed for repeated use across multiple patients or sessions. Since no sterility requirements are specified, proper cleaning and disinfection between uses are critical to prevent contamination. Follow manufacturer guidelines for maintenance to ensure longevity and safe operation, especially for the thermal components in the AT model.
What regulatory pathways have the Therm-X devices undergone, and how does this affect their use in clinical or home settings?
The Therm-X devices have received FDA 510(k) clearance and comply with EU MDR (Medical Device Regulation). This means they meet U.S. and EU standards for safety and effectiveness as Class II devices under FDA classification (870.5800). Clinicians and patients can use them with confidence in both clinical (AT) and home (Home) settings, though adherence to manufacturer instructions and regulatory compliance is essential for proper use.
How do I determine the correct size or model for a patient’s limb, and are there specific sizing options available?
The Therm-X devices come in multiple sizes and models, as indicated by the extensive list of registration numbers (e.g., 3000143502, 3004105270). These likely correspond to different limb circumferences or anatomical regions (e.g., leg, arm, foot). Consult the manufacturer’s sizing guide or product documentation to match the patient’s limb measurements to the appropriate model for optimal compression and fit. The AT model’s portability suggests versatility for various clinical or home use cases.
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. Sources consulted: Therm-X HOME - Zenith Technical Innovations, Therm-X AT - Zenith Technical Innovations, ZENITH THERM-X SERIES USER MANUAL Pdf Download, ZENITH THERM-X SERIES USER MANUAL Pdf Download
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 | K240125 | Class II | Active |
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Manufacturer
- Manufacturer
- Zenith Technical Innovations
Sources (2)
- FDA 510(k) K240125 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026