MOCACARE CORP.

MOCACare Corp. specializes in two primary device categories: portable automatic-inflation electronic sphygmomanometers (blood pressure monitors) designed for arm or wrist use, and single-use public face masks intended for general respiratory protection. These devices are developed to meet common clinical and consumer needs for non-invasive monitoring and infection control.

MOCACare Corp. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s risk-based system. The U.S. regulatory framework ensures that devices like those produced by MOCACare Corp. meet safety, effectiveness, and performance standards before entering the market.

MOCACare Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency and accountability in the supply chain. This listing is required for Class II devices under FDA regulations.

MOCACare Corp.’s devices are classified as Class II under FDA regulations. This classification indicates a moderate level of risk, requiring special controls beyond general controls to ensure their safety and effectiveness. Class II devices undergo additional scrutiny, such as performance standards or post-market surveillance, to mitigate potential risks while allowing broader availability compared to higher-risk Class III devices.