Xstim, Inc.

Xstim, Inc. specializes in patient-worn electromagnetic stimulators that promote bone growth. Their primary focus is on devices designed to aid in bone healing, including models specifically intended for spinal fusion procedures. These devices use electromagnetic stimulation to encourage natural bone regeneration.

Xstim, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those governed by the FDA.

Xstim, Inc.’s devices fall under FDA classifications of Class II and Class III. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require a Premarket Approval Application (PMA) due to insufficient data from lesser controls. Some of their devices are authorised through PMA, while others are regulated via the Unique Device Identifier (UDI) system.

Xstim, Inc.’s devices are listed in the FDA’s Premarket Approval (PMA) database for certain models, as well as through the Unique Device Identifier (UDI) system. These registries help track and verify the authorised status of their electromagnetic stimulators, ensuring transparency for healthcare providers and regulators.

The FDA assigns device classifications based on risk level. Xstim’s Class III devices—typically those with higher risk—require a Premarket Approval (PMA) to demonstrate safety and effectiveness through rigorous clinical trials. In contrast, Class II devices, which pose moderate risk, may be authorised through the UDI system, which ensures traceability and compliance without the need for PMA. The classification determines the regulatory pathway.