SmartDrive Wheelchair Power Assist— 510(k) K151199

Substantially Equivalent

Max Mobility, LLC

FDA 510(k) clearance K151199 for SmartDrive Wheelchair Power Assist, Substantially Equivalent on 2015-07-30. Applicant: Max Mobility, LLC.

Clearance details

Applicant: Max Mobility, LLC
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2015-05-05
Decision date: 2015-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antioch, TN, 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.