[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: 21CFR880.5150]

[Page 381-382]
 
                        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. 880.5150  Nonpowered flotation therapy mattress.

    (a) Identification. A nonpowered flotation therapy mattress is a 
mattress intended for medical purposes which contains air, fluid, or 
other materials that have the functionally equivalent effect of 
supporting a patient and avoiding excess pressure on local body areas. 
The device is intended to treat or prevent decubitus ulcers (bed sores).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is

[[Page 382]]

exempt from the good manufacturing practice regulation in part 820, with 
the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.