[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: 21CFR880.5120]

[Page 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. 880.5120  Manual adjustable hospital bed.

    (a) Identification. A manual adjustable hospital bed is a device 
intended for medical purposes that consists of a bed with a manual 
mechanism operated by an attendant to adjust the height and surface 
contour of the bed. The device includes movable and latchable side 
rails.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 
1989]