BTL Industries, Inc. - FDA 510(k) Cleared Devices

BTL Industries, Inc. is a medical device manufacturer based in Marlborough, US. The company develops therapeutic and rehabilitation technologies across multiple clinical specialties.

BTL Industries has received 42 FDA 510(k) clearances from 42 total submissions since its first clearance in 2010. The company maintains active regulatory status, with its most recent clearance in 2026. Device clearances span General & Plastic Surgery, Physical Medicine, Dental, Neurology, and Gastroenterology & Urology specialties.

The company's product portfolio includes robotic rehabilitation systems, shockwave and laser therapies, electromagnetic and inductive technologies, and essential clinical devices such as ultrasound, electrotherapy, cryotherapy, and diathermy units. Notable product lines include BTL Robotics platforms, high-intensity laser systems, spinal decompression devices, and EMSELLA technology.

Explore the complete regulatory record, including specific device names, product codes, and clearance dates in the database.

Regulatory submissions have been managed by Mmp Medical Associates, LLC and Emergo Group. 2 devices have linked clinical trials registered on ClinicalTrials.gov.