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Electronic Code of Federal Regulations

e-CFR data is current as of November 19, 2019

Title 21Chapter ISubchapter HPart 890Subpart D → §890.3075


Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart D—Physical Medicine Prosthetic Devices


§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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]

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