ThermoPro Shortwave Diathermy
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161862 FDA 510(k)
- FDA Product Code
- IMJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5290 FDA 510(k)
- Regulation Number
- 890.5290 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ThermoPro Shortwave Diathermy is a Shortwave Diathermy device classified under Physical Medicine, designed to apply therapeutic deep heat to tissues via high-frequency electrical currents. It generates heat internally by converting electromagnetic energy, distinguishing it from external heat therapies by delivering thermal effects directly within the target tissue.
This device is intended for use in clinical settings, supplied as a reusable medical instrument under FDA 510(k) clearance (K161862). It operates within Device Class II regulatory standards and is intended for physical medicine applications, with no indication of sterility requirements or MRI compatibility specified. Storage and maintenance instructions are detailed in the accompanying user manual.
Frequently asked questions
What is the ThermoPro Shortwave Diathermy primarily used for in clinical settings?
The ThermoPro Shortwave Diathermy is designed to deliver therapeutic deep heat to tissues by converting electromagnetic energy into internal heat, making it useful for physical medicine applications where targeted tissue warming is required. Unlike external heat therapies, it generates heat directly within the target area, which can aid in pain relief, muscle relaxation, or tissue repair.
Is the ThermoPro device single-use or reusable, and what does this mean for maintenance?
The ThermoPro is classified as a reusable medical instrument, meaning it is intended for repeated use after proper cleaning and maintenance. Since it is not sterile by default, its reuse requires adherence to manufacturer guidelines for disinfection and upkeep, as outlined in the included user manual, to ensure safety and functionality over multiple treatments.
How is the ThermoPro device regulated, and what does this imply for its use?
The ThermoPro Shortwave Diathermy is cleared under the FDA’s 510(k) pathway (K161862) as a Class II device, meaning it has undergone a review to demonstrate substantial equivalence to a legally marketed predicate device. This regulatory classification implies it is intended for physical medicine applications and must be used according to established clinical protocols, though it does not specify sterility or MRI compatibility requirements.
Are there specific storage instructions for the ThermoPro device, and why might they matter?
While the exact storage instructions are detailed in the user manual, the ThermoPro’s reusable nature and exposure to clinical environments likely require protection from moisture, dust, and physical damage. Proper storage ensures longevity, reliability, and compliance with manufacturer recommendations to maintain performance and safety during repeated 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: ThermoPro - Shortwave Diathermy - Zimmer MedizinSystems, ThermoPro | Zimmer MedizinSysteme GmbH, ThermoPro - Zimmer MedizinSysteme - PDF Catalogs | Technical Documentation, ZIMMER THERMOPRO USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161862 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer MedizinSysteme GmbH
Sources (1)
- FDA 510(k) K161862 24 fields · synced Oct 6, 2026