Zhenjiang Rapid Rehab & Instrument Co., Ltd.

Zhenjiang Rapid Rehab & Instrument Co., Ltd. specializes in non-foldable walking chairs, which are designed to assist patients with mobility support. These devices are intended for use in clinical settings or at home to help individuals who have difficulty walking independently. The company’s focus is on assistive mobility solutions, as reflected in their product line.

The company is based in China. While the country of origin influences manufacturing standards and supply chain considerations, regulatory compliance for individual devices—such as classification, registration, and authorization—depends on the jurisdiction where the device is marketed. For example, their walking chairs are listed in the EUDAMED database under Class I, indicating compliance with EU medical device regulations.

The company’s devices, including walking chairs like the RA-RL02336 and RA-RL011E, are registered in the EUDAMED database. This registry is used by the European Union to track medical devices that have undergone the necessary conformity assessment procedures, such as Class I devices, which typically require a Declaration of Conformity but may not always require third-party involvement. Listing in EUDAMED confirms the device’s compliance with EU medical device regulations.

The walking chairs manufactured by the company fall under Class I medical device classification. This classification is generally assigned to low-risk devices that pose minimal risk to patients, such as mobility aids. Class I devices often require a Declaration of Conformity and may involve basic manufacturing controls, though specific requirements can vary by jurisdiction. The classification ensures that these devices meet essential safety and performance standards before being authorized for market.