LIGHT WEIGHT ALUMINUM WALKER— 510(k) K821404

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..

Clearance details

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

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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.