Wicab, Inc.

Wicab, Inc. specializes in video-camera translingual electrical stimulation systems. Their primary product, the BrainPort, is designed to help individuals with sensory impairments, particularly blindness or visual impairment, interpret visual information through tactile feedback. The device uses a camera to capture visual scenes, which are then translated into electrical stimulation patterns on the user’s tongue, allowing them to perceive and navigate their surroundings.

Wicab, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational base, particularly when reviewing compliance or support details for its devices.

Wicab, Inc.’s devices, including the BrainPort, are classified as Class II medical devices under US regulations. This classification typically indicates moderate risk and requires compliance with specific controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Wicab, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that the device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures accurate identification and traceability of medical devices in the marketplace.