Our first-generation Re:Balans medical device is currently undergoing the FDA 510(k) clearance process.

 

During this regulatory review period, the medical-grade Re:Balans is available exclusively for clinical investigations and research applications, as it has not yet received FDA clearance for commercial medical use in the United States.

 

For immediate evaluation and testing, we offer Re:Balans Insight, our non-medical variant designed specifically for customers and research partners seeking to explore the technology's capabilities outside of clinical applications.