The FDA considers ShapeScale (and several other fitness tracking devices) as a “Low-Risk Device”, and does not regulate it for general wellness.
A medical device undergoes extensive testing and evaluation because it is used to diagnose or treat a medical condition. ShapeScale is not used to diagnose or treat a medical condition, it is a fitness device.
Further information about ShapeScale’s FDA classification can be retrieved at
To summarize, ShapeScale’s device category as a Body Analyzer, is exempt from FDA 510(k) clearance.