THREE BEARS(JIANGSU)HEALTHCARE TECHNOLOGY CO., LTD

Three Bears(Jiangsu) Healthcare Technology Co., Ltd specializes in non-collapsible attendant-driven wheelchairs and attendant-only-propelled wheelchairs that are not designed for bariatric use. Their primary product line, Staxi, falls under these categories, serving users who require mobility assistance in a non-folding, manual wheelchair format.

The company is based in the United States. This location is relevant for regulatory compliance and distribution, particularly for devices marketed or sold within the U.S. market.

The company’s devices, including the Staxi wheelchair, are classified as Class I under FDA regulations. This classification applies to devices posing minimal risk to users, often requiring less stringent premarket review. Class I devices are typically exempt from the 510(k) premarket notification process, though they may still need to comply with general controls and labeling requirements.

Yes, the company’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory oversight.