Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is publishing an order setting forth the final determination of a petition requesting exemption from premarket notification (510(k)) requirements for the generic device type, powered patient transport, all other powered patient transport (product code ILK), classified as class II devices. These devices are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs. These devices do not include motorized three-wheeled vehicles or wheelchairs, and are distinct from the device type, powered patient transport, powered patient stairway chair lifts, which is classified separately within the same regulation (product code PCD). FDA is publishing this order in accordance with procedures established in the Federal Food, Drug, and Cosmetic Act (FD&C Act).