IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)— 510(k) K063328

Name: FDA 510(k) clearance K063328
Creator: U.S. Food and Drug Administration
Published: 2007-04-27

Substantially Equivalent

Imc-Heart Way LLC

FDA 510(k) clearance K063328 for IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6), Substantially Equivalent on 2007-04-27. Applicant: Imc-Heart Way LLC. Device class: 2.

Clearance details

Applicant: Imc-Heart Way LLC
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2006-11-03
Decision date: 2007-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Imc-Heart Way LLC

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K063307 — ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)2007-02-27
K063320 — ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)2007-02-27
K063203 — ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)2007-02-13
K063475 — IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)2007-01-23
K063474 — ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)2006-12-22

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.