[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: 21CFR890.3175]

[Page 501]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart D--Physical Medicine Prosthetic Devices
 
Sec. 890.3175  Flotation cushion.

    (a) Identification. A flotation cushion is a device intended for 
medical purposes that is made of plastic, rubber, or other type of 
covering, that is filled with water, air, gel, mud, or any other 
substance allowing a flotation media, used on a seat to lessen the 
likelihood of skin ulcers.
    (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. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38816, July 25, 2001]