[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5120]

[Page 413-414]
 
                        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 (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. 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, with 
respect to general requirements concerning

[[Page 414]]

records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 
1989; 66 FR 38804, July 25, 2001]