Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 890 - Physical Medicine Devices |
Subpart D - Physical Medicine Prosthetic Devices |
§ 890.3150 - Crutch.
Latest version.
-
§ 890.3150 Crutch.
(a) Identification. A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.
(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]