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Aug 28, 2023

BionicM Earns FDA Registration and Class II Exempt Device Listing for Bio Leg™; Its New Motor

Published: Aug 30, 2023 TOKYO, Aug. 30, 2023 /PRNewswire/ -- BionicM, an innovative Japanese medical device startup, is pleased to announce that it has received U.S. Food and Drug Administration (FDA)

Published: Aug 30, 2023

TOKYO, Aug. 30, 2023 /PRNewswire/ -- BionicM, an innovative Japanese medical device startup, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg™; its robotic prosthetic knee. This registration marks a significant milestone in the company's commitment to deliver its robotic prosthetic knee to the USA market in 2024 with Japanese-proven technologies.

"Having your limbs amputated severely limits your life," says Xiaojun Sun, CEO of BionicM, and an above-knee amputee. "While prosthetic limbs have been developed, there are many new ways to improve the lives of amputees with advanced technology. This milestone of achieving our FDA registration underscores our dedication to developing state-of-the-art prosthetic solutions that have the potential to revolutionize mobility of people who have limb loss."

"Bio Leg™ is a groundbreaking prosthetic knee joint which can help improve the daily activities of limb loss in transfemoral patients. We have done several trial fittings in my New York facility with very good results," says Gary Marano, CPO, LPO and CEO of OTF Prosthetics and Orthotics in New York. "Bio Leg™ allows a more natural gait to walk long distances more efficiently along with stability using ramps and inclines. Another functional benefit is to provide an easier sit to stand feature giving the user a quicker and smoother transition when standing up from a chair."

Bio Leg™ features include:

See natural walk with Bio Leg™ from the following video: https://youtu.be/lJzIfDz5BvI?si=I0LwYc2-8AqEof28

To get more information about Bio Leg™, please visit company's homepage: https://bionicm.com/. The company will also be showcasing Bio Leg™ at the upcoming AOPA Conference in Indianapolis in September. Contact [email protected] or visit booth #224.

About BionicM BionicM has been researching on innovative technologies since 2015 at the University of Tokyo, utilizing the world's most advanced robotics research. BionicM won several research grants and awards for start-ups. The robotic prosthetic knee Bio Leg™ also won the Grand Prix "Luminary" in the design concept category of the 2020 "Red Dot Award," one of the world's highest design awards.

Media Contact: Name: Naoko Kita Marketing & Sales Department, BionicM Inc. [email protected] +81-3-3868-2679

View original content to download multimedia:https://www.prnewswire.com/news-releases/bionicm-earns-fda-registration-and-class-ii-exempt-device-listing-for-bio-leg-its-new-motor-robotic-prosthetic-knee-301913712.html

SOURCE BionicM

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