Is Elegaiter a medical device?

No. Elegaiter is not a medical device and is not intended to diagnose, treat, or prevent any disease; it is a fitness and wellness product. Gait data is provided as reference information about your exercise habits and walking characteristics.

CiKLux, the developer of Elegaiter, specializes in clinical trial design and execution. Building on its clinical trial experience with electroceuticals and digital medical products, it participates in Ewha Womans University Mokdong Hospital's Open Innovation Lab, and is preparing plans to evolve toward SaMD (Software as a Medical Device) supporting diagnosis of musculoskeletal and central nervous system conditions, and DTx (Digital Therapeutics) supporting disease management — including chronic disease — both in and outside hospitals. (This describes future plans only and does not indicate that the product is currently certified or approved as a medical device.)