[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: 21CFR890.3075]

[Page 481]
 
                        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. 890.3075  Cane.

    (a) Identification. A cane is a device intended for medical purposes 
that is used to provide minimal weight support while walking. Examples 
of canes include the following: A standard cane, a forearm cane, and a 
cane with a tripod, quad, or retractable stud on the ground end.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the current good manufacturing practice 
regulation 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.