21 CFR § 890.3075 Physical Medicine Devices

§ 890.3075 Cane.

Current through Sep 8, 2026 · Read all of Part 890

(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55993, Dec. 4, 2025]

← § 890.3050 External compression device for internal jugular vein compression.§ 890.3100 Mechanical chair. →