PARAGON REHAB SUPPLIES LLC

Paragon Rehab Supplies LLC specializes in single-use transcutaneous electrical stimulation (TENS) electrodes. These electrodes are designed for temporary skin contact during neuromuscular stimulation therapy, typically used with external electrical stimulation devices to manage pain or facilitate muscle activation in clinical or home settings. The company’s focus is on this specific category of disposable electrodes.

The company is headquartered in the United States. This location is relevant for regulatory compliance, manufacturing standards, and distribution within North America and potentially other markets with U.S.-based supply chains.

Paragon Rehab Supplies LLC’s devices fall under FDA Class II regulation. This classification is assigned based on the risk level of the product—Class II devices generally require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. The company’s electrodes are subject to these regulatory requirements.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry includes critical information like device identification, manufacturing details, and regulatory status to support transparency and traceability in the healthcare system. Listing in the UDI database is mandatory for Class II devices in the U.S.