DECUBITUS CARE PAD— 510(k) K893969

Name: FDA 510(k) clearance K893969
Creator: U.S. Food and Drug Administration
Published: 1989-07-14

Substantially Equivalent

Gulftrade Exim, Inc.

FDA 510(k) clearance K893969 for DECUBITUS CARE PAD, Substantially Equivalent on 1989-07-14. Applicant: Gulftrade Exim, Inc.. Device class: 1.

Clearance details

Applicant: Gulftrade Exim, Inc.
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1989-06-02
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mayfield Heights, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.