SleepSafe® Beds, LLC is registered as a manufacturer, and its products, classified as medical devices, are listed with the Food and Drug Administration (FDA). The FDA does not provide “approval” for this type of medical device as it is exempt under FDA’s Title 21, Chapter I, Subchapter H, Part 880, Subpart F, Section 880.5100 (b).
According the the FDA, “Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.”
For questions regarding FDA regulations, please contact Bob Baldacci, Director of Quality and Regulatory Affairs at SleepSafe® Beds.
Other manufacturers of safety beds may claim approval, but they have misinterpreted the statute.
Posted in: Beds