GEL FLOTATION MATTRESS— 510(k) K813226

Name: FDA 510(k) clearance K813226
Creator: U.S. Food and Drug Administration
Published: 1981-12-02

Substantially Equivalent

Jefferson Industries, Inc.

FDA 510(k) clearance K813226 for GEL FLOTATION MATTRESS, Substantially Equivalent on 1981-12-02. Applicant: Jefferson Industries, Inc.. Device class: 1.

Clearance details

Applicant: Jefferson Industries, Inc.
Product code: Code IKY
Device class: Class 1
Regulation: 21 CFR 880.5150
Advisory panel: General Hospital
Date received: 1981-11-10
Decision date: 1981-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K802781 — BEDDING PADS EGGCREATE PADS1980-12-10
K802833 — TETRA NATAL-MAT WATER FLOTATION MAT.1980-12-10
K780779 — ECONO-FLOAT WATER FLOTATION MATTRESS1978-05-19
K772062 — NEONATAL FLOTATION SYSTEM1977-11-15

More clearances from Jefferson Industries, Inc.

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K813225 — GEL FLOTATION CUSHION1981-12-03
K802603 — ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION1980-11-12

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.