[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5100]

[Page 380-381]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 880.5100  AC-powered adjustable hospital bed.

    (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

[[Page 381]]

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 Sec. 880.9.

[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3, 
1998]