SMARTDRIVE WHEELCHAIR POWER-ASSIST— 510(k) K113621

Name: FDA 510(k) clearance K113621
Creator: U.S. Food and Drug Administration
Published: 2012-07-06

Substantially Equivalent

Max Mobility, LLC

FDA 510(k) clearance K113621 for SMARTDRIVE WHEELCHAIR POWER-ASSIST, Substantially Equivalent on 2012-07-06. Applicant: Max Mobility, LLC. Device class: 2.

Clearance details

Applicant: Max Mobility, LLC
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2011-12-08
Decision date: 2012-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antioch, TN, US

Download summary PDF View on FDA.gov ↗

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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.