[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5560]

[Page 399]
 
                        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. 880.5560  Temperature regulated water mattress.

    (a) Identification. A temperature regulated water mattress is a 
device intended for medical purposes that consists of a mattress of 
suitable size, filled with water which can be heated or in some cases 
cooled. The device includes electrical heating and water circulating 
components, and an optional cooling component. The temperature control 
may be manual or automatic.
    (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.

[45 FR 69682-69737, Oct. 21, l980, as amended at 61 FR 1123, Jan. 16, 
1996; 66 FR 38804, July 25, 2001]