OWELL

Owell specializes in home-use medical devices focused on personal health monitoring. Their portfolio includes blood glucose and blood pressure monitoring systems, which are designed for diabetes management and general health tracking. They also produce single-use manual blood lancing devices, which are essential for obtaining blood samples in glucose monitoring. These devices are intended for use in personal settings, enabling individuals to track their health metrics independently.

Owell is based in the United States. As a manufacturer of medical devices, they operate under the U.S. regulatory framework, which governs the design, production, and distribution of their products. Since their devices fall under Class II classification, they must comply with FDA requirements for these types of diagnostic and monitoring tools, including adherence to quality systems and performance standards.

Yes, Owell’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to verify the identity of the device and its manufacturer. Listing in the UDI database is particularly important for Class II devices, as it helps streamline recalls, track device performance, and maintain compliance with FDA regulations.

Owell’s devices are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. Special controls for Class II devices may include performance standards, post-market surveillance, or design controls, ensuring that these products meet rigorous criteria for their intended use in monitoring blood glucose and blood pressure.