Hengshui Xukang Medical Appliances Co., Ltd

Hengshui Xukang Medical Appliances Co., Ltd specializes in general-purpose patient lifting systems, specifically slings and harnesses. These devices are designed to assist healthcare providers in safely transferring and supporting patients who need mobility assistance or cannot bear weight independently, such as in clinical or home care environments.

The company operates from the United States. While the name suggests a Chinese origin, the manufacturer’s regulatory filings and device listings are aligned with U.S. jurisdiction, indicating its primary operational base is within the country.

The company’s devices, such as the Xukang patient lifting slings and harnesses, are classified as Class I medical devices by the FDA. This classification applies to devices posing minimal risk to patients, often involving general controls like good manufacturing practices (GMP) and labeling requirements. Class I devices typically do not require pre-market approval but must still comply with FDA registration and UDI listing.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to identify specific devices through standardized identifiers. Listing in this database is a requirement for Class I devices under FDA jurisdiction.