RAND SPA

RAND SPA specializes in two primary categories of medical devices: intravascular and intracavitary hyperthermia systems, which include both standalone devices and complete system sets for targeted heating of blood or body cavities; and multi-purpose percutaneous catheters designed for abdominal and thoracic drainage, such as silicone catheters and specialized drainage sets. Examples include hyperthermia systems like the Performer HT and drainage catheters such as the Hang&Go PAC.

RAND SPA is based in the United States, meaning its devices are subject to FDA regulations. The company’s products are classified under FDA’s Class I and Class II categories, which determine the level of scrutiny and requirements for premarket authorisation or clearance. Since these classifications apply to specific devices rather than the company itself, compliance depends on individual device authorisation statuses within the FDA framework.

Yes, RAND SPA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability, transparency, and consistency in device identification across the healthcare system. Listing in the UDI database helps healthcare providers, regulators, and other stakeholders verify device details, track recalls, and maintain accurate records for compliance and patient safety.

RAND SPA’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require only general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorisation, such as 510(k) premarket notifications for Class II, and ensures the device meets specific performance standards before entering the market.