FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403— 510(k) K914125

Name: FDA 510(k) clearance K914125
Creator: U.S. Food and Drug Administration
Published: 1991-10-25

Substantially Equivalent

Ferno

FDA 510(k) clearance K914125 for FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403, Substantially Equivalent on 1991-10-25. Applicant: Ferno. Device class: 2.

Clearance details

Applicant: Ferno
Product code: Code ILJ
Device class: Class 2
Regulation: 21 CFR 890.5100
Advisory panel: Physical Medicine
Date received: 1991-09-13
Decision date: 1991-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, OH, US

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Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.