Fusmobile, Inc. - FDA 510(k) Cleared Devices

Fusmobile, Inc. develops non-invasive therapeutic ultrasound systems for chronic pain management. The company is based in Alpharetta, Georgia, with additional operations in Israel. Fusmobile specializes in High Intensity Focused Ultrasound (HIFU) technology for targeted neural tissue ablation.

Fusmobile has submitted 1 FDA 510(k) application focused on Neurology devices. The company has received 0 FDA 510(k) clearances. This represents a historical regulatory record; the company is currently inactive with no recent clearance activity.

The company's flagship product, the Neurolyser XR, is designed to treat chronic low back pain caused by lumbar facet joint arthritis. The system combines fluoroscopic guidance with focused ultrasound energy to achieve precise thermal ablation of medial branch nerves without surgical incision. This approach aims to reduce procedure time and recovery duration compared to traditional invasive alternatives.

For detailed information on device names, product codes, and clearance timelines, review the full regulatory submission history in the FDA 510(k) database.