Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181149 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5650 FDA 510(k)
- Regulation Number
- 890.5650 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Therm-X Pro, Therm-X AT, and Therm-X Pro Athlete are Powered Inflatable Tube Massagers designed to deliver thermal therapy. These devices provide both cryotherapy (cold therapy) and thermotherapy (heat therapy) to target tissue, reduce inflammation, alleviate pain, and promote recovery in musculoskeletal and soft tissue conditions. Their inflatable tubes conform to the body, allowing for localized application of controlled temperature treatments.
These devices are intended for use in rehabilitation facilities, outpatient clinics, athletic training settings, and homes by or under the supervision of licensed healthcare professionals. Supplied as reusable medical devices, they require proper cleaning and maintenance to ensure sterility and functionality. The devices are classified under FDA 510(k) clearance (K181149) and MDR authorization, adhering to regulatory standards for physical medicine applications. No MRI safety information is specified.
Frequently asked questions
Are the Therm-X Pro series devices designed for home use, or are they primarily intended for clinical or athletic training environments?
The Therm-X Pro, Therm-X AT, and Therm-X Pro Athlete are intended for use in rehabilitation facilities, outpatient clinics, and athletic training settings, as well as in homes. However, they are specifically designed to be used by or under the supervision of licensed healthcare professionals, ensuring proper application and safety, especially when delivering thermal or cryotherapy treatments.
How do I maintain sterility for the reusable Therm-X Pro devices, and what cleaning procedures should I follow?
Since the Therm-X Pro series devices are reusable, maintaining sterility requires proper cleaning and maintenance as outlined by the manufacturer. The inflatable tubes should be cleaned thoroughly after each use to prevent contamination and ensure functionality. Follow the manufacturer’s instructions for disinfection, as improper cleaning could compromise both sterility and performance. Always refer to the provided user manual for specific cleaning protocols.
What temperature ranges can the Therm-X Pro devices deliver, and how do they differ between the models (Therm-X Pro, Therm-X AT, Therm-X Pro Athlete)?
The Therm-X Pro series devices are designed to deliver both cryotherapy (cold therapy) and thermotherapy (heat therapy) to target tissue. While the exact temperature ranges are not specified in the provided data, all three models (Therm-X Pro, Therm-X AT, and Therm-X Pro Athlete) share the same core functionality of providing controlled thermal treatments. The primary distinction lies in their intended application environments—clinical, athletic training, or general rehabilitation—rather than differing temperature capabilities.
Can the Therm-X Pro devices be used in an MRI environment, or are there any MRI safety restrictions?
The provided data does not specify any MRI safety information for the Therm-X Pro series devices. This means there is no explicit confirmation that they are MRI-compatible or safe for use in an MRI environment. If MRI safety is a concern, it is critical to consult the manufacturer’s documentation or verify compatibility directly with Zenith Technical Innovations before use in such settings.
What regulatory pathways have the Therm-X Pro devices undergone, and how does this affect their use in different regions?
The Therm-X Pro, Therm-X AT, and Therm-X Pro Athlete have received FDA 510(k) clearance (K181149) and MDR authorization, indicating compliance with U.S. and European regulatory standards for powered inflatable tube massagers in physical medicine applications. This clearance confirms that the devices meet safety and performance requirements for their intended use in rehabilitation, clinical, and athletic settings. However, regional regulations may still apply, so it’s important to verify local compliance requirements before use.
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: Home - Zenith Technical Innovations, Therm-X AT - Zenith Technical Innovations, Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (K181149) — FDA 510(k ...
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 | K181149 | Class II | Active |
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Manufacturer
- Manufacturer
- Zenith Technical Innovations
Sources (2)
- FDA 510(k) K181149 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026