Halo Sport has been ruled a "health and wellness" device by the FDA; this is a category that the FDA has defined for technologies that are (1) safe and (2) intended for improving performance in healthy users, not for medical use.
Importantly, Halo Sport is not FDA approved for medical applications. It is not a medical device, and therefore is not intended to treat or prevent any health problems. We are hopeful that we will be able to offer Halo Sport as a treatment option in the future, but at the moment, we can only offer Halo Sport as a physical training aid.
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