PHL · Class II · 21 CFR 890.3480

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..

1
Total
1
Cleared
177d
Avg days
2022
Since

List of Powered Exoskeleton devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Powered Exoskeleton devices (product code PHL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Neurology FDA review panel. Browse all Neurology devices →