MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR— 510(k) K061116

Substantially Equivalent

Mobilife, LLC

FDA 510(k) clearance K061116 for MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR, Substantially Equivalent on 2006-07-03. Applicant: Mobilife, LLC.

Clearance details

Applicant: Mobilife, LLC
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2006-04-21
Decision date: 2006-07-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Delafield, WI, 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.