How do you handle that you are entering the regulated market of medical devices?
Just picking out one single almost random (because, you know, cited above) claim:
"The nine sensors can recognize an emergency from the change of your vital data. So, If you are unconscious or injured, it can automatically sends an emergency call and informs up to 10 pre-defined persons or institutions via encrypted SMS, MMS or E-Mail (you have the possibility to predefine it)."This gets you into the realm of directive 93/42/EC in europe, so do you have the necessary files and clinical trial plannings accordingly?
Your US representative also will get a call from a responsible FDA officer, asking you if you want to file a 510K (with such a novelty impossible, as there is no predicate device) or a PMA, I guess. (Those guys have police rights and even carry weapons
)
(Similar troubles in other countries well possible)