Tuesday, March 22, 2016

WHILL Model M powered wheelchair recieved FDA clearance. Video.

WHILL Model M doesn’t hold you back, it powers you forward. With simplistic beauty and revolutionary design, Model M provides mobility in a versatile, stylish and unobtrusive way.

CAUTION: Federal law restricts this device to sale by or on the order of a physician

Press Release:

To the WHILL Community,
Finally! We have received FDA clearance on a new powered wheelchair that will be released in the coming months.
WHILL Model M, which keeps the 4WD, patented all-directional wheels and sleek design of our introductory Model A, was designed with wheelchair users in mind. It can be customized with additional medical necessities including arm supports, different back support options, and ankle huggers. The additional features are not available with Model A, which is not a medical device and will not be submitted to the FDA for clearance.
The FDA's decision involved an extensive review of Model M, and it means that physicians can now prescribe our technologically advanced powered wheelchair as a medical device. In addition, we are 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.  
FDA clearance is inline with our mission to change the perception of mobility devices such as wheelchairs and scooters, which are often stigmatized for having a clinical appearance. Our founders were inspired by their friend, a wheelchair user, who had given up on going even just a few blocks to the grocery store due to his chair's lack of functionality and the stigma he felt as a wheelchair user.
“We are proud to have received FDA clearance,” says our CEO and Co-Founder Satoshi 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. ”
Thank you to everyone that has shown their support for WHILL along the way. We couldn't have made it to this point without you!

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