SKIL-CARE BED RAIL PADS— 510(k) K791993

Name: FDA 510(k) clearance K791993
Creator: U.S. Food and Drug Administration
Published: 1979-10-26

Substantially Equivalent

Skil-Care Corp.

FDA 510(k) clearance K791993 for SKIL-CARE BED RAIL PADS, Substantially Equivalent on 1979-10-26. Applicant: Skil-Care Corp.. Device class: 1.

Clearance details

Applicant: Skil-Care Corp.
Product code: Code FNJ
Device class: Class 1
Regulation: 21 CFR 880.5120
Advisory panel: General Hospital
Date received: 1979-10-03
Decision date: 1979-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K884542 — SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED1988-11-21
K881725 — ENVIROTENT (BED)1988-11-08

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K963458 — PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS1996-10-18
K963459 — SUPPORT VEST1996-10-15
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Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

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.