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

Burke, Inc. is a marketing research and innovation firm based in Cincinnati, Ohio, with a manufacturing facility in McHenry, Illinois. The company has over 90 years of experience in research, strategy, and insights across multiple industries, including healthcare.

Burke, Inc. has received 7 FDA 510(k) clearances from 7 total submissions, with no denied submissions on record. The company's regulatory focus has been exclusively on Physical Medicine devices, spanning from 1984 to 2006. Notable cleared products include thermal therapy systems, motorized mobility devices, and therapeutic pads designed for physical medicine applications.

The company is inactive in FDA regulatory submissions, with no clearances issued in more than 15 years. Burke's 510(k) history represents a historical record of device development and regulatory compliance in the physical medicine sector.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database.