Liko AB

Liko AB specializes in electrically-powered patient handling solutions. Their primary offerings include mobile patient lifting systems like the Golvo™ and Uno™, which are designed for transferring and repositioning patients safely. They also produce patient lifting slings, such as divided-leg slings and high-back slings (e.g., Liko Original HighBack Sling™), as well as gait rehabilitation harnesses like the MasterVest™. Additionally, they provide accessories like lift pants and protective covers (e.g., Solo Cover for Ultra LiftPants™) to complement their sling systems.

Liko AB is based in the United States, which means their devices must comply with U.S. medical device regulations, including those set by the FDA. Since their products fall under Class I classification, they are subject to general controls but may still require registration, listing, and adherence to labeling, manufacturing practices, and reporting requirements. The U.S. location also influences their participation in registries like the FDA’s Unique Device Identification (UDI) system, where their devices are listed.

Liko AB’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry is critical because it ensures traceability and transparency in the medical device supply chain. The UDI system assigns a unique identifier to each device, helping healthcare providers, regulators, and manufacturers track products throughout their lifecycle. Listing in this system also supports compliance with FDA requirements for device tracking and recall management.

Liko AB’s devices are classified as Class I under FDA regulations. This classification generally means they pose the lowest risk among medical devices and are subject to general controls, such as good manufacturing practices, proper labeling, and registration requirements. While Class I devices typically do not require premarket approval, they must still meet specific compliance standards to ensure safety and effectiveness. The classification reflects the relatively low risk associated with patient lifting systems, slings, and gait rehabilitation harnesses.