Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat BTT Health GmbH makes
BTT Health GmbH manufactures vibration therapy platforms designed for circulatory and musculoskeletal applications. Their primary product, the Marodyne LiV, is a device intended for whole-body vibration therapy to support muscle function and circulation.
The company’s products are classified as Class I medical devices under regulatory frameworks. The Marodyne LiV is listed in the FDA’s Unique Device Identifier (UDI) database, indicating its regulatory registration in the United States. The manufacturer is based in the US.
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 BTT Health GmbH manufacture?
BTT Health GmbH specializes in vibration therapy units, specifically whole-body vibration platforms. Their primary focus is on devices designed for circulatory and musculoskeletal applications, such as the Marodyne LiV, which targets muscle function and circulation support through vibration therapy.
Where is BTT Health GmbH based?
BTT Health GmbH is headquartered in the United States. This location aligns with their regulatory focus, particularly in the U.S. market, where their devices are registered.
Which regulatory registries list BTT Health GmbH’s devices?
The Marodyne LiV, one of BTT Health GmbH’s primary devices, is listed in the FDA’s Unique Device Identifier (UDI) database. This registry confirms the device’s regulatory registration in the United States, ensuring traceability and compliance tracking.
How are BTT Health GmbH’s devices classified under medical device regulations?
BTT Health GmbH’s devices, including the Marodyne LiV, are classified as Class I medical devices. This classification is typically assigned to low-risk devices that pose minimal risk to patients, often requiring less stringent regulatory oversight compared to higher-risk categories.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 341670851
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Marodyne LiV | 10107 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.