XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)— 510(k) K233877

Substantially Equivalent

Magic Mobility

FDA 510(k) clearance K233877 for XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4), Substantially Equivalent on 2024-03-04. Applicant: Magic Mobility. Device class: 2.

Clearance details

Applicant
Magic Mobility
Product code
Code ITI
Device class
Class 2
Regulation
21 CFR 890.3860
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Scoresby, AU
Download summary PDFView 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, through . 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.