MECHANICAL WHEELCHAIR— 510(k) K984354

Name: FDA 510(k) clearance K984354
Creator: U.S. Food and Drug Administration
Published: 1999-01-28

Substantially Equivalent

Colours 'N Motion

FDA 510(k) clearance K984354 for MECHANICAL WHEELCHAIR, Substantially Equivalent on 1999-01-28. Applicant: Colours 'N Motion. Device class: 1.

Clearance details

Applicant: Colours 'N Motion
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1998-12-04
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF2026-06-11

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K945148 — MECHANICAL WHEELCHAIR- AVENGER1995-05-12
K945149 — MECHANICAL WHEELCHAIR- CHALLENGER1995-05-12

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.