Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121059 FDA 510(k)
- FDA Product Code
- IMG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5860 FDA 510(k)
- Regulation Number
- 890.5860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Soleoline, Soleo Stim, Soleo Sono, and Soleo Sonostim are Stimulators, Ultrasound and Muscle, designed for applying therapeutic deep heat. These devices combine electrical stimulation with ultrasound technology to target muscle tissue, promoting tissue repair, reducing pain, and improving mobility in physical medicine applications. They are classified as Class II medical devices under FDA regulations, ensuring compliance with stringent performance and safety standards.
These devices are supplied as reusable systems intended for clinical use in physical medicine settings. They are not sterile and require proper cleaning and maintenance between uses. The devices operate within MRI-safe parameters, allowing for safe use in environments where magnetic resonance imaging is conducted. Authorized under FDA 510(k) clearance and MDR compliance, they are distributed with multiple model references for compatibility with various therapeutic protocols.
Frequently asked questions
Are these devices intended for single-use or can they be reused in a clinical setting?
The Soleoline, Soleo Stim, Soleo Sono, and Soleo Sonostim are designed as reusable systems for clinical use in physical medicine. Since they are not sterile, proper cleaning and maintenance between uses are required to ensure safety and performance. This aligns with their classification as reusable medical devices under FDA regulations.
What types of therapeutic applications are these devices primarily used for?
These devices combine electrical stimulation with ultrasound technology to deliver therapeutic deep heat, targeting muscle tissue. They are intended for physical medicine applications, including promoting tissue repair, reducing pain, and improving mobility—commonly used in rehabilitation and pain management settings.
Can these devices be used safely in an MRI environment?
Yes, the Soleoline, Soleo Stim, Soleo Sono, and Soleo Sonostim are designed to operate within MRI-safe parameters, allowing for safe use in facilities where magnetic resonance imaging is conducted. This feature is explicitly noted in the device’s specifications.
How many model references are included in the distribution of these devices?
The Soleoline system is distributed with multiple model references (listed under the `fei_number` and `registration_number` fields), ensuring compatibility with various therapeutic protocols in physical medicine. These references correspond to different configurations or settings within the device family.
What regulatory pathways have these devices undergone, and what does that mean for their use?
The devices are authorized under FDA 510(k) clearance (with a decision code of *SESE*, indicating substantial equivalence) and comply with MDR (Medical Device Regulation) standards. This means they meet FDA’s safety and performance requirements for Class II devices and are approved for clinical use in physical medicine settings as described in the device’s intended purpose.
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 | K121059 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Medizinsystems GmbH
Sources (2)
- FDA 510(k) K121059 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026