Author: WHILL, Inc. – Contact: whill.us
2016-03-26 – WHILL, Inc. receives U.S. Food and Drug Administration clearance on technologically advanced wheelchair model that will be released in the coming months.
WHILL, Inc. (WHILL) has 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.
“We look forward to working with physicians in the United States by providing them with new modern wheelchair option for their patients.”
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.
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Woman seated in the WHILL Model M wheelchair
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…