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Sign in to claim this brandWhat MTS Medical AG makes
MTS Medical AG manufactures freestanding electric massage devices designed for muscle relaxation and pain relief, as well as dermatological extracorporeal shock wave therapy systems for treating skin conditions. Their portfolio also includes spark-gap lithotripsy systems for breaking down kidney and urinary tract stones, alongside a range of shock wave therapy devices for orthopedic and soft tissue applications.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. MTS Medical AG is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does MTS Medical AG manufacture?
MTS Medical AG produces a variety of medical devices, including freestanding electric massagers for muscle relaxation and pain relief, dermatological extracorporeal shock wave therapy systems for treating skin conditions, and spark-gap lithotripsy systems designed to break down kidney and urinary tract stones. Their portfolio also includes shock wave therapy devices for orthopedic and soft tissue applications, such as the VIASURE, Softwave Gold Li, and OrthoGold100®.
Where is MTS Medical AG based?
MTS Medical AG is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight and compliance, as it operates within the FDA’s jurisdiction for device authorisation.
How are MTS Medical AG’s devices classified under FDA regulations?
MTS Medical AG’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorisation.
Are MTS Medical AG’s devices listed in any regulatory databases?
Yes, MTS Medical AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- trtllc.com
- —
- —
- [email protected]
- Phone
- (888) 862-6162
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 342585299
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Viasure | OW100-US | FDA UDI | Class I | Active |
| Softwave Gold Li | OW100S-US | FDA UDI | Class II | Active |
| Ow100s | OW100S-US | FDA UDI | Class I | Active |
| DermaGold100® | OW100-US | FDA UDI | Class II | Active |
| OrthoGold100® | OW100-US | FDA UDI | Class I | Active |
| Mts | LG380 | FDA UDI | Class II | Active |
| Dermagold100 | OW100S-US | FDA UDI | Class II | Active |
| ChiroGold | OW100S-US | FDA UDI | Class I | Active |
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