Analytics For Life, Inc.

Analytics For Life, Inc. specializes in multiparameter physiologic analysis workstations, which monitor and analyze multiple patient vital signs and cardiac functions simultaneously. Their primary product line includes systems like the CorVista®, which can optionally integrate modules for coronary artery disease (CAD) assessment or arterial blood gas (PH) analysis. These devices are engineered for clinical environments to provide continuous, comprehensive patient monitoring.

Analytics For Life, Inc. is headquartered in the United States, which means its devices are subject to FDA regulations. Since the company’s products are Class II medical devices, they require authorization through pathways like the 510(k) premarket notification process or compliance with the Unique Device Identifier (UDI) system. The FDA’s regulatory databases list these devices, ensuring traceability and adherence to US medical device standards.

Analytics For Life, Inc.’s devices are included in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track authorized medical devices in the US, ensuring transparency in their classification, compliance, and market authorization status. The inclusion in these databases confirms the devices meet FDA requirements for Class II medical devices.

Analytics For Life, Inc.’s devices are classified as Class II medical devices under the US Food and Drug Administration’s regulatory framework. This classification applies to products that generally pose moderate risk to patients and require special controls to ensure safety and effectiveness. Class II devices are authorized through pathways like the 510(k) process, which demonstrates substantial equivalence to a legally marketed predicate device, or compliance with UDI requirements.