Neuroqore, Inc.

Neuroqore, Inc. specializes in magnetic neural stimulation systems, primarily focusing on transcranial magnetic stimulation (TMS) technology. Their product line includes TMS applicators, coil coolers, arm mounts for positioning, and complete TMS systems designed for therapeutic use, such as treatment-resistant major depressive disorder (MDD). These devices leverage magnetic fields to stimulate neural activity in targeted brain regions.

Neuroqore, Inc. is headquartered in the United States, which means its devices are subject to FDA regulatory requirements. Since the company’s products fall under Class II classification, they undergo premarket notification (510(k)) processes to demonstrate substantial equivalence to existing legally marketed devices. This classification reflects a moderate risk level, requiring compliance with specific controls to ensure safety and effectiveness.

Neuroqore, Inc.’s devices are included in the FDA’s 510(k) database, which tracks premarket submissions for Class II devices, and the FDA’s Unique Device Identifier (UDI) system. The UDI database ensures traceability and identification of medical devices throughout their lifecycle, while the 510(k) listing confirms regulatory review for market authorization. Both registries help healthcare providers and regulators verify compliance and device details.

Neuroqore, Inc.’s devices are classified as Class II under FDA regulations, indicating a moderate risk to patients. This classification requires manufacturers to comply with special controls—such as performance standards, labeling requirements, or post-market surveillance—to ensure safety and effectiveness. The 510(k) process is used to demonstrate that new devices meet these controls, often by showing equivalence to a previously authorized predicate device. This classification balances regulatory oversight with innovation for therapeutic applications like TMS.