[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: 21CFR890.3520]

[Page 482]
 
                        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. 890.3520  Plinth.

    (a) Identification. A plinth is a flat, padded board with legs that 
is intended for medical purposes. A patient is placed on the device for 
treatment or examination.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedure in subpart E of part 
807. The device is also exempt from the current good manufacturing 
practice regulations 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.