FDA Product Code PHL: Powered Exoskeleton
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.
Leading manufacturers include Samsung Electronics Co., Ltd., Cyberdyne, Inc. and Rewalk Robotics Ltd. Dba Lifeward.
FDA 510(k) Cleared Powered Exoskeleton Devices (Product Code PHL)
About Product Code PHL - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code PHL since 2014, with 23 receiving FDA clearance (average review time: 183 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under PHL have taken an average of 237 days to reach a decision - up from 178 days historically. Manufacturers should account for longer review timelines in current project planning.
PHL devices are reviewed by the Neurology panel. Browse all Neurology devices →