[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: 21CFR874.3375]

[Page 367]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874_EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart D_Prosthetic Devices
 
Sec. 874.3375  Battery-powered artificial larynx.

    (a) Identification. A battery-powered artificial larynx is an 
externally applied device intended for use in the absence of the larynx 
to produce sound. When held against the skin in the area of the 
voicebox, the device generates mechanical vibrations which resonate in 
the oral and nasal cavities and can be modulated by the tongue and lips 
in a normal manner, thereby allowing the production of speech.
    (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. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38800, July 25, 2001]