COMFORT WINDJOY SCOOTER, MODEL LY-EW302— 510(k) K022369

Substantially Equivalent

Comfort Orthopedic Co., Ltd.

FDA 510(k) clearance K022369 for COMFORT WINDJOY SCOOTER, MODEL LY-EW302, Substantially Equivalent on 2002-10-11. Applicant: Comfort Orthopedic Co., Ltd..

Clearance details

Applicant: Comfort Orthopedic Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2002-07-22
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

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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.