Medical device means instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software; its utility is mainly obtained through physical and other means, not through pharmacological, immunological, or metabolic means, or although there is participation in these means, but only plays a supplementary role.
Thus, the Violet Star Physical Therapy Device should also be considered a medical device.