COMMODE CHAIR 98200— 510(k) K842651

Name: FDA 510(k) clearance K842651
Creator: U.S. Food and Drug Administration
Published: 1984-08-07

Substantially Equivalent

Guardian Products Co., Inc.

FDA 510(k) clearance K842651 for COMMODE CHAIR 98200, Substantially Equivalent on 1984-08-07. Applicant: Guardian Products Co., Inc.. Device class: 1.

Clearance details

Applicant: Guardian Products Co., Inc.
Product code: Code ILS
Device class: Class 1
Regulation: 21 CFR 890.5050
Advisory panel: Physical Medicine
Date received: 1984-07-10
Decision date: 1984-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ILS

product code ILS

Death: 4
Injury: 200
Total: 204

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.