Xr, LLC

Xr, LLC specializes in manufacturing water-based sexual lubricants. These products come in multiple sizes, including 2oz, 4oz, 8oz, 10oz, 16oz, and 34oz, as well as a branded variant called Passion Natural Water Based Lubricant. The focus is exclusively on lubricants, with no other device categories listed.

Xr, LLC is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products are classified as Class II medical devices, they fall under the FDA’s oversight framework, requiring compliance with specific requirements for safety, performance, and labeling.

Xr, LLC’s devices are classified as Class II medical devices by the FDA. This classification indicates that while they pose moderate risks, they require general controls (like labeling and manufacturing practices) *and* special controls (such as performance standards or post-market surveillance) to ensure safety and effectiveness. The classification influences regulatory requirements, including submission pathways like the 510(k) process.

Xr, LLC’s devices are listed in the FDA’s 510(k) database and the Unique Device Identifier (UDI) system. The 510(k) registry tracks premarket submissions demonstrating that a device is substantially equivalent to a legally marketed predicate, while the UDI system ensures accurate identification, tracking, and traceability of devices throughout their lifecycle for safety and quality monitoring.