Cleartrac Technologies, LLC

Cleartrac Technologies, LLC specializes in urine flowmeters, which come in both reusable and single-use versions. These devices measure urinary flow rates to aid in clinical assessments. Additionally, the company produces battery chargers designed specifically for noninvasive medical devices, ensuring they can be powered externally. The focus is on urinary assessment tools and supporting equipment for noninvasive devices.

Cleartrac Technologies, LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance context, particularly for devices marketed in the US.

Cleartrac Technologies, LLC’s devices are classified as Class II under FDA regulations. This classification is based on the level of risk associated with the devices—Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Urine flowmeters and noninvasive device chargers fall into this category due to their clinical use and potential impact on patient care.

Yes, Cleartrac Technologies, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability. Listing in this database is a requirement for many FDA-regulated devices to facilitate regulatory oversight and market surveillance.