UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES— 510(k) K002318

Name: FDA 510(k) clearance K002318
Creator: U.S. Food and Drug Administration
Published: 2000-10-11

Substantially Equivalent

United Chair Mfg., LLC

FDA 510(k) clearance K002318 for UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES, Substantially Equivalent on 2000-10-11. Applicant: United Chair Mfg., LLC. Device class: 2.

Clearance details

Applicant: United Chair Mfg., LLC
Product code: Code INO
Device class: Class 2
Regulation: 21 CFR 890.3110
Advisory panel: Physical Medicine
Date received: 2000-07-31
Decision date: 2000-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

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K123834 — EASYSTAND BANTAM MEDIUM2013-08-13
K112944 — FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES2011-12-30
K101723 — COMPACT WHEELCHAIR PLATFORM2010-12-23
K091578 — LIFT CHAIR, MODEL T32009-12-02

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.