Stethoai LLC

Stethoai LLC specializes in portable electronic medical devices. Their primary offerings include automatic-inflation electronic sphygmomanometers for measuring blood pressure, available in arm or wrist versions. Additionally, they produce electronic acoustic stethoscopes that convert heart and lung sounds into digital signals for diagnostic evaluation.

Stethoai LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction.

Stethoai LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory, safety, and market surveillance purposes, ensuring traceability and compliance.

Stethoai LLC’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a moderate risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for each product.