DOUBLE SUPPORT PONCHO/SLIDER PONCHO— 510(k) K963447

Name: FDA 510(k) clearance K963447
Creator: U.S. Food and Drug Administration
Published: 1996-10-07

Substantially Equivalent

Skil-Care Corp.

FDA 510(k) clearance K963447 for DOUBLE SUPPORT PONCHO/SLIDER PONCHO, Substantially Equivalent on 1996-10-07. Applicant: Skil-Care Corp.. Device class: 1.

Clearance details

Applicant: Skil-Care Corp.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1996-09-03
Decision date: 1996-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yonkers, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.