WALKER/CRUTCH BAG— 510(k) K811485

Name: FDA 510(k) clearance K811485
Creator: U.S. Food and Drug Administration
Published: 1981-06-16

Substantially Equivalent

Fred Sammons, Inc.

FDA 510(k) clearance K811485 for WALKER/CRUTCH BAG, Substantially Equivalent on 1981-06-16. Applicant: Fred Sammons, Inc.. Device class: 1.

Clearance details

Applicant: Fred Sammons, Inc.
Product code: Code ITJ
Device class: Class 1
Regulation: 21 CFR 890.3825
Advisory panel: Physical Medicine
Date received: 1981-05-26
Decision date: 1981-06-16
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.