MODEL 938 BATHING SYSTEM— 510(k) K880355

Substantially Equivalent

Ferno Ille-Forge

FDA 510(k) clearance K880355 for MODEL 938 BATHING SYSTEM, Substantially Equivalent on 1988-02-16. Applicant: Ferno Ille-Forge.

Clearance details

Applicant: Ferno Ille-Forge
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 1988-01-26
Decision date: 1988-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsport, PA, 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.