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Sign in to claim this brandMiha Bodytec GmbH
US
Last updated May 27, 2026
What Miha Bodytec GmbH makes
Miha Bodytec GmbH manufactures transcutaneous neuromuscular electrical stimulation (TENS/NMES) systems designed for physical therapy applications. These devices are intended to facilitate muscle stimulation, pain management, and rehabilitation through controlled electrical impulses delivered via electrodes. The portfolio includes multiple iterations of a single core product line, targeting clinical and home-use settings for therapeutic interventions.
The company’s devices fall under Class II regulatory classification in the US, requiring pre-market notification (510(k)) and Unique Device Identification (UDI) compliance. Products are listed in the FDA’s 510(k) and UDI registries. The manufacturer 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 Miha Bodytec GmbH manufacture?
Miha Bodytec GmbH specializes in transcutaneous neuromuscular electrical stimulation (TENS/NMES) systems. These devices are designed for physical therapy, delivering controlled electrical impulses to stimulate muscles, manage pain, and aid in rehabilitation. The company’s portfolio focuses on a single core product line, with multiple versions tailored for both clinical and home-use settings.
Where is Miha Bodytec GmbH based?
Miha Bodytec GmbH is based in the United States. The company’s location is relevant for understanding its regulatory and operational context, particularly in relation to US-based medical device compliance.
How are Miha Bodytec GmbH’s devices classified in the US?
Miha Bodytec GmbH’s devices fall under Class II regulatory classification in the US. This classification requires pre-market notification via a 510(k) submission and compliance with Unique Device Identification (UDI) requirements, as these devices pose moderate risk and are intended for therapeutic use in physical therapy.
Which regulatory registries list Miha Bodytec GmbH’s devices?
Miha Bodytec GmbH’s devices are listed in the FDA’s 510(k) registry (for pre-market notifications) and the FDA’s UDI (Unique Device Identification) registry, ensuring traceability and compliance with US medical device regulations. These registries help track authorized devices for monitoring and oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 551434728
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| miha bodytec | miha bodytec II | FDA UDI | Class II | Active |
| miha bodytec | miha bodytec m.ove | FDA UDI | Class II | Active |
| miha bodytec | i-body connect wireless | FDA UDI | Class II | Active |
| Miha Bodytec II | K182519 | FDA 510(k) | Class II | Active |
| Miha Bodytec II | K221498 | FDA 510(k) | Class II | Active |
| miha bodytec II | K201975 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Miha Bodytec Gmbh Gersthofen Bavaria · DE FEI 3010385841