【News】CYBERDYNE Inc. has begun seeking approval from the U. S. Food and Drug Administration (FDA)

CYBERDYNE Inc. has begun seeking approval from the U. S. Food and Drug Administration (FDA) to export Robot Suit HAL for Medical Use to the United States.  A Section 513(g) Request for Information summarizing the characteristics of the device and requesting a judgement clarifying the device classification was submitted, and received by the FDA on June 27, 2014

CYBERDYNE Inc. must receive approval from the FDA before introducing devices such as Robot Suit HAL for Medical Use to the United States.  As Robot Suit HAL for Medical Use is a new medical device with an unprecedented innovative design, CYBERDYNE Inc. requested a clarification regarding the device classification and will conclude the application process after receiving the FDA’s response to the 513(g) submission.