Extreme X8— 510(k) K211574

Substantially Equivalent

Magic Mobility

FDA 510(k) clearance K211574 for Extreme X8, Substantially Equivalent on 2021-07-09. Applicant: Magic Mobility.

Clearance details

Applicant: Magic Mobility
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2021-05-21
Decision date: 2021-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scoreby, AU

Download summary PDF View on FDA.gov ↗

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.