[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: 21CFR886.1140]

[Page 434]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 886--OPHTHALMIC DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 886.1140  Ophthalmic chair.

    (a) Identification. An ophthalmic chair is an AC-powered or manual 
device with adjustable positioning in which a patient is to sit or 
recline during ophthalmological examination or treatment.
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]