[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: 21CFR880.5550]

[Page 417]
 
                        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. 880.5550  Alternating pressure air flotation mattress.

    (a) Identification. An alternating pressure air flotation mattress 
is a device intended for medical purposes that consists of a mattress 
with multiple air cells that can be filled and emptied in an alternating 
pattern by an associated control unit to provide regular, frequent, and 
automatic changes in the distribution of body pressure. The device is 
used to prevent and treat decubitus ulcers (bed sores).
    (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, 1980, as amended at 63 FR 59229, Nov. 3, 
1998]