Neuro Therm, Inc.

Neuro Therm, Inc. specializes in devices used for percutaneous radio-frequency ablation, primarily monopolar denervation probes. Their portfolio includes both single-use and reusable ablation probes, reusable and single-use electrical connection cables, and single-use electrosurgical return electrodes. These devices are designed for controlled tissue ablation procedures, often used in pain management and neurosurgical applications.

Neuro Therm, Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight, manufacturing standards, and compliance with US medical device regulations.

Neuro Therm, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US medical device regulations, allowing healthcare providers and regulators to verify device authorisation status.

All of Neuro Therm, Inc.’s devices fall under Class II classification in the US. This classification is assigned based on the level of risk associated with the device’s intended use and design. Class II devices typically require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

The FDA’s 510(k) process ensures that Neuro Therm, Inc.’s devices meet regulatory requirements by demonstrating substantial equivalence to a legally marketed predicate device. Meanwhile, UDI listings provide a unique identifier for each device, improving tracking, traceability, and transparency in the supply chain. Together, these processes help ensure patient safety and regulatory compliance for their products.