WHILL Receives FDA Clearance for Next-Generation Wheelchair
Major milestone for WHILL that brings innovation to an industry desperately in need of change
Jun 10, 2024
San Francisco, CA, March 22, 2016 — WHILL, Inc. (WHILL) today announced that it has received U.S. Food and Drug Administration (FDA) clearance on a new model that will be released in the coming months.
The FDA decision involved an extensive review of Model M, a technologically advanced wheelchair. Model M was developed to provide consumer oriented product design with superior maneuverability utilizing their patented omni-directional wheel. The clearance will allow WHILL to reach out to the 6.8 million mobility device users in the United States*, especially those who have been waiting for an FDA-cleared WHILL product since the nationwide launch of the Model A mobility device in June of 2015.
FDA clearance means that physicians can now prescribe Model M as a medical device. In addition, the company is planning to apply to Healthcare Common Procedure Coding System (HCPCS) to receive Pricing, Data Analysis and Coding (PDAC) so the product can be recognized by insurance such as Medicare. Model M was designed with wheelchair users in mind and also includes medical necessities such as arm supports, pressure relief handles, and different back support options. These features are not available with its predecessor Model A, which is not a medical device and will not be submitted to the FDA for clearance.
“FDA clearance of Model M represents a major milestone for our team and our customers in the US healthcare system,” says WHILL’s co-founder and CEO Satoshi Sugie. “We look forward to working with physicians in the United States by providing them with new modern wheelchair option for their patients.” This is in line with WHILL’s mission to change the perception of mobility devices such as wheelchairs and scooters. The clinical appearance of these devices can give the impression of illness, making the user self-conscious and uncomfortable.
Since the beginning WHILL has actively sought feedback from wheelchair users and applied it to their designs. The founders were inspired by their friend, a wheelchair user, who had given up on going even just a few blocks to the grocery store. His chair lacked the functionality needed to navigate the imperfect pathways and he was also facing the emotional struggle caused by the stigma he felt as a wheelchair user.
“We are proud to have received FDA clearance,” said Sugie. “In order to realize our vision of mobility solutions, we need be able to address the millions of mobility device users who are suffering from lack of innovation in the industry. FDA’s review is a uniquely rigorous process we undertook because we remain deeply committed to ensuring that our products are stringently tested, and that patients and their physicians have access to the world’s most advanced wheelchair.”
WHILL Model M is the second model launched by the company following the award winning WHILL Model A.
*Data Reference :http://www.disabled-world.com/pdf/mobility-report.pdf
About WHILL
WHILL, Inc. is a personal mobility device company founded in 2013 by former Nissan, Sony, and Olympus engineers and designers. WHILL’s mission is to make transportation smart and fun for everybody.
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