[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.3710]

[Page 493]
 
                        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. 890.3710  Powered communication system.

    (a) Identification. A powered communication system is an AC- or 
battery-powered device intended for medical purposes that is used to 
transmit or receive information. It is used by persons unable to use 
normal communication methods because of physical impairment. Examples of 
powered communication systems include the following: a specialized 
typewriter, a reading machine, and a video picture and word screen.
    (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. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]

[[Page 494]]