Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
Information
Type
Rule
Regulated products
Medical Devices
Published
January 14, 2020
Last updated
January 14, 2020
Description
Document number 2020-00295. The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification (510(k)) requirements for powered wheeled stretchers (product code INK). These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). This order exempts powered wheeled stretchers, class II devices, from 510(k) requirements, subject to certain conditions for exemption. This exemption from 510(k) requirements is immediately in effect for powered wheeled stretchers. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)