I guess they have double blind trials to prove that it works?
If not, it’s a scam. Not even a chance it’s not a scam at that point. What you describe is a medical device, according to the FDA, so if it actually worked they’d have certain approvals. If it does anything and it’s not classified by the FDA, it’s illegal.
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From https://www.fda.gov/medical-devices/classify-your-medical-de...
Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).