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Comment by pavel_lishin | Hacker News Reader

Excellent presentation, but leaves me with two questions.

1. Why the iPhone-only connector?

2. My stepfather, back in ye olden days, tried to create a similar product (albeit, this was before ubiquitous mobile computing devices) and ran into all sorts of regulatory FDA issues because they classified it as a medical device, and required the construction of a hoop factory before you were allowed to even start jumping through them.

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Re: #2, from http://www.zensorium.com/tinke/specs.html:

   WARNING

   Tinké is NOT a medical device. Tinké and its associated
   applications should not be used to diagnose, treat, or
   prevent any disease or medical condition. Always seek 
   the advice of a qualified medical professional.

It seems like the same type of logic applied to over-the-counter drugs that call themselves supplements -- it's not a "drug" if the marketers don't make certain claims. In the case of Tinké, they are providing a means for collecting data and do not make any claims that the product will directly affect your health.

The FDA's definition of what is or is not a medical device has nothing at all to do with nutritional supplements; those are covered by entirely separate rules. In reality this product probably is a Class 1 medical device, which is subject to only very light regulation. The FDA might decide to ignore it for a while until it becomes a larger issue. If you talk to actual FDA staffers they're trying to encourage innovation in this space by not being too heavy handed, while still protecting patients.

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