federal_register: 2019-19978

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2019-19978 Medical Devices; Exemption From Premarket Notification: Class II; Powered Wheeled Stretcher; Request for Comments Notice The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. 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). FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act). 2019-09-16 2019 9 https://www.federalregister.gov/documents/2019/09/16/2019-19978/medical-devices-exemption-from-premarket-notification-class-ii-powered-wheeled-stretcher-request-for https://www.govinfo.gov/content/pkg/FR-2019-09-16/pdf/2019-19978.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. These devices are battery-powered tables with wheels that...  

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