Optumhealth Care Solutions, Inc.

Optumhealth Care Solutions, Inc. specializes in electronic medical devices primarily focused on infusion therapy. Their portfolio includes ambulatory non-insulin infusion pumps, which are designed for portable use outside of clinical settings, and single-channel bedside infusion pumps, intended for controlled medication delivery in hospital or home care environments. They also develop telehealth applications to support remote patient monitoring and care coordination.

Optumhealth Care Solutions, Inc. is based in the United States. Since the company operates within the U.S. regulatory framework, its devices are subject to FDA oversight. The FDA classifies these devices as Class II, which means they pose moderate risks and require special controls to ensure safety and effectiveness. The company’s devices are authorised through the FDA’s 510(k) premarket notification process and must comply with Unique Device Identification (UDI) requirements.

The devices produced by Optumhealth Care Solutions, Inc. are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the Unique Device Identification (UDI) system. These registries ensure transparency and traceability of medical devices authorised for use in the U.S., helping healthcare providers and regulators verify compliance and device details.

The devices manufactured by Optumhealth Care Solutions, Inc., such as their ambulatory and bedside infusion pumps, are classified as Class II under FDA regulations. This classification is determined based on the level of risk associated with the device. Class II devices require special controls beyond general controls to mitigate moderate risks, such as those related to infusion pumps, which must ensure accurate dosing and safe operation to prevent patient harm.