JOSON-CARE ENTERPRISE CO., LTD. GUISHAN FACTORY

Joson-Care Enterprise Co., Ltd. specializes in manual and electrically powered hospital beds, including basic electric home beds, basic electric hospital beds, and manual hospital stretchers. These devices are primarily designed for use in both in-patient care facilities and home settings, offering adjustable support and mobility for patients.

The company is based in the U.S., specifically operating from its Guishan factory. This location ensures its devices comply with U.S. medical device regulations, including classification under FDA’s requirements. The factory’s location also influences the regulatory pathways and compliance standards the company follows for its products.

Joson-Care Enterprise Co., Ltd.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory and clinical purposes.

The company’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory scrutiny and compliance requirements each device must meet.