PRESS RELEASE

2017.12.18 update

【News Flash】 Medical HAL obtained medical device approval from the U.S. FDA

On December 17 (EST) CYBERDYNE,INC. (the “Company”) received a approval (marketing clearance) of HAL for Medical Use Lower Limb Type (Medical HAL) as a medical device from the US Food and Drug Administration (“FDA”). More details will be reported later on, but Medical HAL became the only medical device with these two FDA categories: Neurological Devices (21 CFR 882.5050 -HCC) and Physical Medicine Devices (21 CFR 890.3480 -PHL).
As soon as the details of the approval are confirmed, it will be disclosed.

Link: FDA: 510(k) Premarket Notification
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171909

 

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