tag:blogger.com,1999:blog-7900715461504740407.post9118838489504966548..comments2024-03-09T06:30:19.307-06:00Comments on Agile Complexification Inverter: Luke Arm - How long between invention and innovation?Davidhttp://www.blogger.com/profile/12435527405159930692noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-7900715461504740407.post-38425957989671575122009-10-12T10:40:45.207-05:002009-10-12T10:40:45.207-05:00It probably shouldn't require FDA approval. Se...It probably shouldn't require FDA approval. See this note on how non-invasive prosthetic orthopedic devices are regulated:<br />http://openprosthetics.wikispot.org/Federal_Regulation_of_Prostheses<br /><br />I would imagine that DEKA's concern is in getting an advance ruling that the device is indeed a Class I(Exempt) device, as it should be if its method of interacting with the patient is equivalent to existing devices.Jon Khttps://www.blogger.com/profile/07856189864331819557noreply@blogger.com