21 C.F.R. § 890.3825

Current through October 31, 2024
Section 890.3825 - Mechanical walker
(a)Identification. A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.
(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.

21 C.F.R. §890.3825

48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817 , July 25, 2001