IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)— 510(k) K063475

Substantially Equivalent

Imc-Heart Way LLC

FDA 510(k) clearance K063475 for IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS), Substantially Equivalent on 2007-01-23. Applicant: Imc-Heart Way LLC.

Clearance details

Applicant: Imc-Heart Way LLC
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2006-11-16
Decision date: 2007-01-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Fort Myers, FL, US

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.