[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: 21CFR890.3725]

[Page 503-504]
 
                        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. 890.3725  Powered environmental control system.

    (a) Identification. A powered environmental control system is an AC- 
or battery-powered device intended for medical purposes that is used by 
a patient to operate an environmental control function. Examples of 
environmental control functions include the

[[Page 504]]

following: to control room temperature, to answer a doorbell or 
telephone, or to sound an alarm for assistance.
    (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]