Is your device an exoskeleton?
ASTM F3323 Definition: an exoskeleton is a wearable device that augments, enables, assists, and/or enhances physical activity through mechanical interaction with the body.
FDA Regulation (21 CFR 890.3480): A powered exoskeleton is a prescription device composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes. It facilitates movement of one or multiple lower extremity joints (e.g., hip, knee, ankle).
Enter details about your device to check if it is similar to an exoskeleton per ASTM and FDA standards.
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