Product Classification

• 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 Code: PHL
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Physical Medicine 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 16-231 ISO 10328 Second edition 2016-06-01
  Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
• 16-232 IEC 80601-2-78 Edition 1.0 2019-07
  Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Third Party Review

Not Third Party Eligible