Is the Big Blue a Medical Device? By : bens 0 Comments The Big Blue is not a medical device. It is not registered with the FDA. We make no claims as such. It is not intended to diagnose, treat, or be used in therapy for any medical condition. Categories: Uncategorized Post navigation Previous Previous post: In our city (Houston, TX) we already have high ozone days that instigate warnings for respiratory health. If I am using ozone in my indoor garden, will this increase my health risk?