SAFEWAYZ, LLC

SafeWayZ, LLC specializes in sexual lubricants. Their primary product, Mr. Hankey’s Breed’R Cum Lube, is formulated as a lubricious solution intended for use during intimate activities. This category falls under FDA’s classification of Class II devices, which typically require special controls to ensure safety and effectiveness.

SafeWayZ, LLC is headquartered in the United States. The company’s location is relevant for regulatory inquiries, as it determines the governing body (in this case, the FDA) that oversees its devices.

Yes, SafeWayZ, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes.

SafeWayZ, LLC’s sexual lubricant, such as Mr. Hankey’s Breed’R Cum Lube, is classified as a Class II device by the FDA. This classification indicates that the device poses moderate risk and requires special controls beyond general controls to mitigate risks, such as performance standards or post-market surveillance.