Rooti Labs , Ltd.

Rooti Labs, Ltd. specializes in Class II medical devices. Specifically, they develop the Rooti Rx ECG Event Recorder, a portable device designed to capture and record electrocardiogram (ECG) data, and the Rooti Link APP Software, which enables remote monitoring and data transmission for cardiac event analysis. These devices are intended for use in diagnosing and managing cardiac conditions.

Rooti Labs, Ltd. is headquartered in the United States. The company’s location in the US aligns with its regulatory focus on FDA compliance, as evidenced by the 510(k) clearance process for its devices.

Rooti Labs, Ltd.’s devices, including the Rooti Rx ECG Event Recorder and Rooti Link APP Software, are listed under the FDA’s 510(k) clearance pathway. This classification indicates that the devices have undergone a premarket notification process to demonstrate substantial equivalence to legally marketed predicate devices, ensuring compliance with FDA regulations.

Rooti Labs, Ltd.’s devices are classified as Class II medical devices by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. The Rooti Rx ECG Event Recorder and Rooti Link APP Software fall into this category due to their role in capturing and transmitting cardiac data, which requires validation of performance and usability to mitigate potential risks.