I’m actually using this biomedical device for my capstone project. It’s called the comfortprene wrist and thumb-wrap. It’s a general wellness product that would fall into the second category of the FDA’s definition of said general wellness products. The reason being is that this brace is ideal for dealing and aiding ailments such as wrist arthritis, sprains, tendinitis and carpal tunnel syndrome. It falls under the second category because it is attempting to treat certain conditions while making direct reference to known diseases/ailments. The brace is providing a general improvement to function.

Source: https://www.ncmedical.com/item_1213.html
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