Whill receives FDA approval for the Model M, its new mobility device

Japanese startup Whill’s Model M, a motorized wheelchair alternative, has received clearance from the Food and Drug Administration in the United States. This means that the Model M can now be prescribed by physicians as a medical device and covered by insurance.

Whill has raised about $12.85 million in funding so far from investors including the venture capital arm of Japanese telecom giant NTT DoCoMo. The company previously sold another mobility device, called the Type-A, in the United States, which it didn’t seek FDA approval for.

Whill’s products use a patented wheel that allows users to make tighter turns in all directions, increasing their mobility and allowing them to maneuver easily on rough or sloping surfaces. The Model M includes several new features, including arm supports, pressure relief handles, and adjustable back support, that are necessary in medical devices.

In a statement, co-founder and CEO Satoshi Sugie, who was inspired to launch Whill after seeing how difficult it was for a disabled friend to navigate with a traditional wheelchair, said passing the stringent FDA clearance process means the company will be able to market the Model M to the 6.8 million mobility device users in the U.S., as well as medical professionals:

“FDA clearance of the Model M represents a major milestone for our team and our customers in the U.S. healthcare system. We look forward to working with physicians in the United States by providing them with new modern wheelchair options for their patients.”

The company’s team includes engineers and designers who previously worked Nissan, Sony, and Olympus and draw inspiration from auto design to create more attractive alternatives to electric wheelchairs, with the goal of removing the stigma attached to mobility devices. The Model M will have a market price of $13,995.

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