Shanghai Bangbang Robotics Co., Ltd.

Shanghai Bangbang Robotics Co., Ltd. specializes in occupant-controlled electric-motor-driven wheelchairs. These devices are designed to provide mobility assistance, allowing users to move independently. Examples include models like the Robooter E60 and the Robooter, which fall under the category of electric wheelchairs.

The company operates from the United States. While the name suggests a Shanghai origin, the manufacturing and business operations are conducted within the US market.

The devices produced by Shanghai Bangbang Robotics Co., Ltd., such as the Robooter E60 and other electric wheelchairs, are classified as Class II medical devices. This classification is determined based on regulatory criteria, which typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness.

Yes, the devices manufactured by Shanghai Bangbang Robotics Co., Ltd. are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices to ensure transparency and traceability in the healthcare system.