TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2— 510(k) K011707

Substantially Equivalent

Merits Medical Industries Co., Ltd.

FDA 510(k) clearance K011707 for TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2, Substantially Equivalent on 2001-08-03. Applicant: Merits Medical Industries Co., Ltd..

Clearance details

Applicant: Merits Medical Industries Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2001-06-04
Decision date: 2001-08-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Cape Coral, FL, 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.