Jiangxi Wulinxiang Biological Technology Co., LTD.

Jiangxi Wulinxiang Biological Technology Co., Ltd. specializes in manufacturing water-based human sexual lubricants. These products are designed for personal use to improve comfort during intimate activities. The company produces both branded lubricants, such as JXWLX®, XUANAI®, LIKKCUT®, and AAV®, as well as generic human lubricants.

The company is based in the United States. While the name suggests a Chinese origin, the manufacturing operations and regulatory filings are conducted through its US-based entity.

The company’s human sexual lubricants are classified as Class II medical devices by the FDA. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as lubricants that may interact with sensitive tissues or materials.

The company’s devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the 510(k) clearance process, ensuring compliance with FDA requirements for Class II medical devices.

Sexual lubricants are classified as medical devices because they are intended to be used for diagnostic, therapeutic, or mitigating health purposes. In this case, they are designed to reduce friction and irritation during intimate activities, which can help prevent discomfort or injury. The FDA regulates them as Class II devices due to their potential impact on sensitive tissues and the need for quality control.