ExoRank

Medical-device status

By ExoRank Research Desk · Last reviewed

A regulatory classification tied to an intended medical purpose, jurisdiction, and exact product. A consumer exoskeleton is not a medical device merely because it assists walking, and an overseas approval does not automatically apply in the United States.

Why it matters

Medical claims demand regulator-level evidence. ExoRank keeps consumer products out of rehabilitation rankings unless the exact device and intended use have the required regulatory support.

Primary reference

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

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