GEL FLOTATION MATTRESS— 510(k) K813226

Substantially Equivalent

Jefferson Industries, Inc.

FDA 510(k) clearance K813226 for GEL FLOTATION MATTRESS, Substantially Equivalent on 1981-12-02. Applicant: Jefferson Industries, Inc..

Clearance details

Applicant: Jefferson Industries, Inc.
Product code: Code IKY
Advisory panel: General Hospital
Date received: 1981-11-10
Decision date: 1981-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code IKY

product code IKY

Death: 5
Malfunction: 491
Other: 4
Total: 500

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.