KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320— 510(k) K031309

Substantially Equivalent

Kuann Dah Industry Co., Ltd.

FDA 510(k) clearance K031309 for KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320, Substantially Equivalent on 2003-07-31. Applicant: Kuann Dah Industry Co., Ltd..

Clearance details

Applicant: Kuann Dah Industry Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2003-04-24
Decision date: 2003-07-31
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.