Wavi Co.

Wavi Co. specializes in analytical non-scalp cutaneous electrodes, which are used for electrophysiological monitoring. Their primary products include EEG (electroencephalography) systems, such as the WAVi SCAN EEG System and Accessories, as well as single-use electrode contacts like the WAVi Headset and WAVi eSoc Electrode Contacts. These devices are designed for clinical applications where precise skin-surface electrical recordings are required.

Wavi Co. is based in the United States. Their devices are regulated under FDA pathways, specifically listed under 510(k) pre-market notifications and UDI (Unique Device Identification) requirements. Since their products fall under Class II classification, they must comply with FDA’s regulatory framework for moderate-risk devices, which includes performance standards and labeling requirements.

Wavi Co.’s devices are documented in FDA’s 510(k) registry, which tracks pre-market submissions for Class II medical devices, and the FDA’s UDI database, which ensures traceability and compliance for marketed products. These registries help verify regulatory clearance and device identification for healthcare providers and authorities.

Wavi Co.’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls (e.g., performance standards, post-market surveillance) to ensure safety and effectiveness. The company’s EEG systems and electrode contacts fall into this category due to their clinical use in monitoring brain activity.