SMART SOFT HEALTHCARE AD

Smart Soft Healthcare AD specializes in spinal and orthopedic support devices. Their portfolio includes the CoLumboX, CoLumbo, and CoLumbo C-Spine, which are designed for cervical and lumbar stabilization applications. These devices are intended to assist in the management of spinal conditions by providing targeted support and alignment.

Smart Soft Healthcare AD is headquartered in Bulgaria. The company’s location influences its regulatory compliance and submission processes, particularly for markets like the United States, where devices may follow pathways such as the FDA’s 510(k) process.

Smart Soft Healthcare AD’s devices are classified as Class II, which typically requires submission through pathways like the FDA’s 510(k) process for market authorization in the United States. This classification is based on the devices’ intended use in spinal and orthopedic stabilization, where moderate risk is associated with their design and function.

The devices manufactured by Smart Soft Healthcare AD—CoLumboX, CoLumbo, and CoLumbo C-Spine—are classified as Class II. This classification is determined by regulatory bodies based on the level of risk associated with the device’s intended use. Class II devices generally require additional controls beyond general controls but do not pose the highest risk level (Class III).