PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER— 510(k) K031897

Substantially Equivalent

Imc-Heart Way LLC

FDA 510(k) clearance K031897 for PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER, Substantially Equivalent on 2003-09-23. Applicant: Imc-Heart Way LLC.

Clearance details

Applicant: Imc-Heart Way LLC
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2003-06-19
Decision date: 2003-09-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Fort Myers, 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.