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U.S. Department of Health and Human Services

Product Classification

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Device powered exoskeleton
Regulation Description Powered lower extremity exoskeleton.
Definition A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.
Physical State The device is comprised of external, powered, orthotic components that rely on controllers and/or sensors.
Technical Method The device facilitates movement of one or multiple lower extremity joints (e.g. hip, knee, ankle).
Target Area The device is intended to be used on the lower extremity. It may be used unilaterally, bilaterally, on a single joint, or on multiple joints.
Regulation Medical Specialty Physical Medicine
Review Panel Neurology
Product CodePHL
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.3480
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible