Free Wheelchair Mission is one of 13015 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Free Wheelchair Mission - FDA 510(k) Cleared Devices
Recent clearances: GEN 4 JOY Wheelchair, GEN_2 and GEN_3 Mechanical Wheelchairs, GEN_3
4
Total
4
Cleared
0
Denied
Free Wheelchair Mission, is a humanitarian, faith-based nonprofit that designs and manufactures cost-efficient, durable wheelchairs for developing countries. The organization has distributed nearly 1.6 million wheelchairs to people with disabilities across 95 countries, with a manufacturing facility in Yorba Linda, California.
The company has received 4 FDA 510(k) clearances from 4 total submissions since its first clearance in 2012. All submissions focus on Physical Medicine devices, with the most recent clearance in 2026, demonstrating continued regulatory activity and product innovation.
Free Wheelchair Mission's cleared devices include mechanical wheelchair generations and the GEN 4 JOY Wheelchair, reflecting the company's commitment to advancing mobility solutions. The organization operates with strong financial accountability, dedicating 78% of operating expenses to serve people with disabilities worldwide.
Explore the company's complete FDA 510(k) clearance history, device names, product codes, and clearance dates in the regulatory database.
510(k) submissions have been managed by Sharon Rockwell, Consultant as regulatory consultant.
FDA 510(k) Regulatory Record - Free Wheelchair Mission
4 devices