N K I

N K I specializes in diagnostic caloric vestibular stimulation systems, which are primarily used for evaluating vestibular function. These devices perform tests like caloric irrigation and video nystagmography (VNG) to assess inner ear and balance disorders. The focus is on portable and assessment-oriented systems, such as the I-Portal Super VNG and I-Portal Portable Assessment System, designed for clinical diagnostics.

N K I is headquartered in the United States, meaning its devices fall under FDA jurisdiction. Since these products are classified as Class II devices, they are subject to FDA’s regulatory controls, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and compliance.

N K I’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, a public registry that tracks medical devices authorized for sale in the U.S. This database helps healthcare providers, regulators, and manufacturers verify device details, including classification, manufacturer information, and compliance status.

N K I’s diagnostic caloric vestibular stimulation systems are classified as Class II devices by the FDA. This classification indicates they pose a moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices are subject to performance standards, post-market surveillance, and other regulatory requirements to maintain compliance.