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Is ShapeScale FDA approved?

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.

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