LIGHT WEIGHT ALUMINUM WALKER— 510(k) K821404

Name: FDA 510(k) clearance K821404
Creator: U.S. Food and Drug Administration
Published: 1982-05-21

Substantially Equivalent

Manuco Manufacturing Co., Inc.

FDA 510(k) clearance K821404 for LIGHT WEIGHT ALUMINUM WALKER, Substantially Equivalent on 1982-05-21. Applicant: Manuco Manufacturing Co., Inc.. Device class: 1.

Clearance details

Applicant: Manuco Manufacturing Co., Inc.
Product code: Code ITJ
Device class: Class 1
Regulation: 21 CFR 890.3825
Advisory panel: Physical Medicine
Date received: 1982-05-11
Decision date: 1982-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITJ

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More clearances from Manuco Manufacturing Co., Inc.

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K821403 — LIGHT WEIGHT ALUMINUM CRUTCHES1982-06-21
K821405 — MAGUN BASE I.V. POLE1982-06-16
K821402 — LIGHT WEIGHT ALUMINUM CANES1982-04-21

Adverse events under product code ITJ

product code ITJ

Death: 8
Injury: 571
Other: 2
Total: 581

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.