21 C.F.R. § 890.3825 Mechanical walker.
Title 21 - Food and Drugs
(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 regulations 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 38817, July 25, 2001]
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart D—Physical Medicine Prosthetic Devices
§ 890.3825 Mechanical walker.
