eCFR Reference Browser

---

title: "21 CFR §880.5100"

source: "https://www.ecfr.gov/current/title-21/section-880.5100"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "880"

part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"

subpart_code: "F"

subpart_subject: "General Hospital and Personal Use Therapeutic Devices"

section_number: "880.5100"

section_subject: "AC-powered adjustable hospital bed."

cfr_reference: "21 CFR 880.5100"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

§880.5100 - AC-powered adjustable hospital bed.