FOLDING SHOWER-COMMODE CHAIR— 510(k) K802745

Name: FDA 510(k) clearance K802745
Creator: U.S. Food and Drug Administration
Published: 1980-11-19

Substantially Equivalent

Winco Winfield Co., Inc.

FDA 510(k) clearance K802745 for FOLDING SHOWER-COMMODE CHAIR, Substantially Equivalent on 1980-11-19. Applicant: Winco Winfield Co., Inc.. Device class: 1.

Clearance details

Applicant: Winco Winfield Co., Inc.
Product code: Code INM
Device class: Class 1
Regulation: 21 CFR 890.3100
Advisory panel: Physical Medicine
Date received: 1980-11-03
Decision date: 1980-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K802744 — FOLDING ROLL-ABOUT CHAIR1980-11-19

Adverse events under product code INM

product code INM

Death: 3
Total: 3

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.