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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 used for medical purposes that is placed over a person's paralyzed or weakened limbs for the purpose of providing ambulation.
Physical State The device is a wearable exoskeleton device that allows the user to enable ambulation over the course of the day. The control of the device is achieved through a wrist-worn user-operated wireless communicator, tilt sensor and specific body movements
Technical Method The movement of the swing leg is controlled by a seat of gears and DC motors at the knee and hip joints. Minimizing energy expenditure with gait approximation is critical for maximizing battery life between charges.
Target Area The device legs consist of left and right interconnect hip and knee segments. Multiple attachment straps are mounted along the length of each leg. The pelvic band support provides a structure to join the two legs together and the pelvic strap helps hold the user firmly in the system. A tilt sensor is mounted on the left side of the pelvic band. The ankle/foot bed holds the calves of the user to the system.
Regulation Medical Specialty Physical Medicine
Review Panel Neurology
Product CodePHL
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Submission Type 510(k)
Regulation Number 890.3480
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible