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Sign in to claim this brandHASOMED GmbH
US
Last updated May 23, 2026
What HASOMED GmbH makes
HASOMED GmbH manufactures external gait-enhancement electrical stimulation systems designed to support mobility and rehabilitation. These devices use functional electrical stimulation (FES) to assist patients in improving walking patterns and reducing gait impairments, including models like the RehaStim 2 and RehaMove 2.
The company’s products are classified as Class II medical devices under regulatory frameworks, with authorisations granted through FDA 510(k) and UDI listings. These devices are intended for use in clinical and home rehabilitation settings, adhering to US regulatory standards.
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 HASOMED GmbH manufacture?
HASOMED GmbH specializes in external gait-enhancement electrical stimulation systems. These devices use functional electrical stimulation (FES) to help patients improve walking patterns and reduce gait impairments, particularly in rehabilitation settings. The focus is on mobility support, making these tools useful for both clinical and home-based therapy.
Where is HASOMED GmbH based, and how does that affect its regulatory compliance?
HASOMED GmbH is based in the US, which means its devices are subject to US regulatory requirements. Since its products are classified as Class II medical devices, they undergo evaluation through pathways like the FDA’s 510(k) premarket notification process and UDI (Unique Device Identification) listings to ensure compliance with US standards for safety and performance.
Which regulatory registries or databases list HASOMED GmbH’s devices?
HASOMED GmbH’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s UDI (Unique Device Identification) registry. These listings confirm the devices meet US regulatory requirements for Class II medical devices, ensuring traceability and compliance with FDA standards.
How are HASOMED GmbH’s devices classified under medical device regulations?
HASOMED GmbH’s gait-enhancement electrical stimulation systems are classified as Class II medical devices. This classification is based on their intended use—assisting mobility and rehabilitation through functional electrical stimulation—where moderate regulatory oversight is required to ensure safety and effectiveness without the higher scrutiny of Class III devices.
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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- Phone
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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
- 341439008
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RehaStim 2 for Hocoma | FES01050 | FDA UDI | Class II | Active |
| RehaStim 2 | FES01090 | FDA UDI | Class II | Active |
| RehaStim 2 | FES01050 | FDA UDI | Class II | Active |
| RehaStim 2 / RehaMove 2 | FES00005 | FDA UDI | Class II | Unknown |
| DigiTrainer S | DigiTrainer S | FDA UDI | Class I | Unknown |
| RehaStim2 | FES01092 | FDA UDI | Class II | Active |
| DigiTrainer | DigiTrainer | FDA UDI | Class I | Unknown |
| RehaStim 2 | K162683 | FDA 510(k) | Class II | Active |
| Rehastim 2, Erigopro (fes) | K132416 | FDA 510(k) | Class II | Active |
| Rehastim & Rehamove | K073237 | FDA 510(k) | Class II | Active |
| Rehastim 2, Rehamove 2 | K112844 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Hasomed Gmbh Magdeburg Saxony-Anhalt · DE FEI 3006141275