Glottal Enterprises, Inc.

Glottal Enterprises, Inc. specializes in electroglottographs, which are devices designed to measure vocal fold vibrations. These measurements are used clinically to assess voice disorders or laryngeal function. The most common device produced falls under this category, such as the Two Channel Electroglottograph EG2-PCX2.

Glottal Enterprises, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly in markets where domestic manufacturers may have specific requirements or advantages.

The devices produced by Glottal Enterprises, Inc., such as electroglottographs, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.

Yes, the devices manufactured by Glottal Enterprises, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory oversight.