INNOVA WHEELCHAIR— 510(k) K110788

Name: FDA 510(k) clearance K110788
Creator: U.S. Food and Drug Administration
Published: 2011-05-06

Substantially Equivalent

Columbia Medical Manufacturing, LLC

FDA 510(k) clearance K110788 for INNOVA WHEELCHAIR, Substantially Equivalent on 2011-05-06. Applicant: Columbia Medical Manufacturing, LLC. Device class: 1.

Clearance details

Applicant: Columbia Medical Manufacturing, LLC
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2011-03-22
Decision date: 2011-05-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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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.