Medical-device status
By Avery Brooks · 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 this term 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.
How to evaluate it in a product claim
- Search the regulator database for the exact product and manufacturer.
- Read the stated indication, intended population and use environment.
- Check whether supervision, training or prescription conditions apply.
- Verify the jurisdiction instead of transferring status between countries.
What it should not be confused with
A CE mark, an FDA establishment registration, a research study or a general wellness claim is not automatically evidence that an exact device is cleared for a particular medical indication.
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Primary references
These references define the standards, workplace, human-factors or regulatory context. Product-level claims still require the exact model documentation.
fda.gov