Sopur GmbH

Sopur GmbH specializes in manual wheelchairs intended for mobility assistance. Their product line includes standard and customizable models suited for both indoor and outdoor environments, focusing on enhancing user mobility and independence.

Sopur GmbH is based in the United States. Since the company’s devices are manufactured and marketed there, they must comply with U.S. regulatory requirements, including classification and listing under the FDA’s 510(k) pathway for their wheelchair products.

Sopur GmbH’s wheelchairs are classified as Class I devices under FDA regulations. This classification applies because wheelchairs are considered low-risk, non-invasive mobility aids that do not require active controls or significant patient interaction beyond basic use. Class I devices typically undergo general controls (e.g., manufacturing practices, labeling) rather than pre-market approval.

Sopur GmbH’s wheelchairs are listed in the FDA’s 510(k) database, which tracks devices that have been cleared through the 510(k) premarket notification process. This pathway demonstrates that the manufacturer has shown their device is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA requirements.