LOTUS BLAKE ESTEEM SCOOTER— 510(k) K103771

Substantially Equivalent

Letrix Power Hangzhou Pty, Ltd.

FDA 510(k) clearance K103771 for LOTUS BLAKE ESTEEM SCOOTER, Substantially Equivalent on 2011-05-06. Applicant: Letrix Power Hangzhou Pty, Ltd..

Clearance details

Applicant: Letrix Power Hangzhou Pty, Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2010-12-27
Decision date: 2011-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

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Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.