QUANTUM BARIATRIC 451— 510(k) K112815

Substantially Equivalent

Pride Mobility Product Corporration

FDA 510(k) clearance K112815 for QUANTUM BARIATRIC 451, Substantially Equivalent on 2012-02-29. Applicant: Pride Mobility Product Corporration.

Clearance details

Applicant: Pride Mobility Product Corporration
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2011-09-27
Decision date: 2012-02-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Exeter, PA, US

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.