Yurob Rehabilitation Medical Co., Ltd

Yurob Rehabilitation Medical Co., Ltd specializes in electrically powered mobility devices, focusing on occupant-controlled electric-motor-driven wheelchairs and scooters. Their portfolio includes models like the TRAVEL BUGGY and a variety of electrically powered wheelchairs, such as the YLB-W-0812 series and the YC-01. These devices are designed to assist individuals with mobility needs by providing powered transport solutions.

Yurob Rehabilitation Medical Co., Ltd is based in China. While the company’s headquarters location doesn’t directly determine regulatory classification, it means their devices must comply with both Chinese regulatory requirements and international standards (such as EU and FDA regulations) if marketed globally. Their products are listed in EUDAMED and FDA databases, indicating they are registered for distribution in the EU and the US.

Yurob’s devices are listed in three key regulatory databases: EUDAMED (for European Union compliance), the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) system. These listings reflect their registration and tracking requirements under EU and US medical device regulations, ensuring transparency and traceability for authorized distribution.

Yurob’s devices fall under EU Class I and Class II classifications, which determine their regulatory oversight level. Class I devices are generally low-risk (e.g., simple mobility aids), while Class II devices involve moderate risks (e.g., powered wheelchairs with specific controls or features) and require stricter compliance measures like conformity assessments. The FDA categorizes these devices similarly, with Class II often requiring premarket notifications (510(k)) to demonstrate safety and effectiveness before commercialization.