Diacor Inc.

Diacor Inc. specialises in patient handling devices, primarily motorised patient lifting systems like the Zephyr Patient Positioning and Transfer System. These systems are designed to assist healthcare professionals in safely transferring and positioning patients within clinical environments. Additionally, the company produces radiological whole-body positioners and overlays, such as the Diacor Overlay, which help immobilise patients during imaging procedures to ensure accurate and repeatable scans.

Diacor Inc. is based in the United States. Their devices are authorised for use in both the EU and US markets, with regulatory submissions recorded in eudamed (for EU compliance), FDA 510(k) submissions (for US pre-market notifications), and FDA UDI listings (to ensure unique device identification). This reflects their focus on meeting regulatory requirements in key global healthcare markets.

Diacor Inc.’s devices are listed in eudamed (the EU database for medical devices), FDA 510(k) submissions (for US pre-market clearance), and FDA UDI listings (to track device identification). These registries are used because they serve as official records of device authorisation: eudamed ensures compliance with EU Medical Device Regulations, while FDA submissions and UDIs confirm regulatory clearance in the US under Class I and Class II classifications.

Diacor Inc.’s devices fall under Class I and Class II classifications. Class I devices generally pose minimal risk and require less stringent regulatory oversight, while Class II devices involve a higher level of risk (e.g., patient positioning systems) and require pre-market notifications like FDA 510(k) submissions to demonstrate safety and effectiveness. The classification depends on factors like intended use, risk level, and potential patient exposure.

Devices listed under FDA 510(k) are typically Class II products that require pre-market notification to demonstrate substantial equivalence to a legally marketed predicate device. Meanwhile, FDA UDI listings are mandatory for all medical devices (including Class I) to ensure unique identification for tracking, traceability, and regulatory compliance. The overlap occurs because Class II devices must meet both requirements: they undergo 510(k) clearance *and* receive a UDI to maintain regulatory records.