Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
fda-device · Food and Drug Administration · Rule · Published 2020-01-14 · Effective 2020-01-14 · 85 FR 2018
Document
Document number
2020-00295
Federal Register citation
85 FR 2018
CFR reference
21 CFR 890
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2020-01-14
Effective date
2020-01-14
HHS docket
Docket No. FDA-2019-P-3347
Abstract
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).