AEROLET TOILET LIFT, MODEL AER-01— 510(k) K031045

Name: FDA 510(k) clearance K031045
Creator: U.S. Food and Drug Administration
Published: 2003-07-10

Substantially Equivalent

Economic Holland B.V.

FDA 510(k) clearance K031045 for AEROLET TOILET LIFT, MODEL AER-01, Substantially Equivalent on 2003-07-10. Applicant: Economic Holland B.V.. Device class: 2.

Clearance details

Applicant: Economic Holland B.V.
Product code: Code INO
Device class: Class 2
Regulation: 21 CFR 890.3110
Advisory panel: Physical Medicine
Date received: 2003-04-30
Decision date: 2003-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clemmons, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code INO

product code INO

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.