21 CFR § 890.3825 - Mechanical walker.

---
identifier: "/us/cfr/t21/s890.3825"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 890.3825 - Mechanical walker."
title_number: 21
title_name: "Food and Drugs"
section_number: "890.3825"
section_name: "Mechanical walker."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "890"
part_name: "PHYSICAL MEDICINE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53047, Nov. 23, 1983, unless otherwise noted."
cfr_part: "890"
---


# 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 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 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025]