Bioelectronics Corp (BIEL)

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Question, was that "Trinket" an FDA Cleared Medical Device or a Wellness Product?

<<<<< stupid trinket that I bought online for brucitis, trinket did not do a thing >>>>>

As I am sure you are aware ActiPatch is a FDA Cleared Medical Device cleared for use of Pain Relief on the entire Musculoskeletal System.

III. General Wellness Products

A general wellness product, for the purposes of this guidance, has (1) an intended use that
relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an
intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact
of certain chronic diseases or conditions and where it is well understood and accepted that
healthy lifestyle choices may play an important role in health outcomes for the disease or
condition.

If the product’s intended uses are not limited to the above general wellness intended uses,
this guidance does not apply.

The first category of general wellness intended uses involve claims about sustaining or
offering general improvement to functions associated with a general state of health that do
not make any reference to diseases or conditions. For the purposes of this guidance, this
first category of general wellness claims relate to:

· weight management,
· physical fitness, including products intended for recreational use,
· relaxation or stress management,
· mental acuity,
· self-esteem (e.g., devices with a cosmetic function that make claims related only to
self-esteem),
· sleep management, or
· sexual function.