HEARTWAY POWER WHEELCHAIR— 510(k) K132856

Name: FDA 510(k) clearance K132856
Creator: U.S. Food and Drug Administration
Published: 2014-07-15

Substantially Equivalent

Heartway Medical Products Co., Ltd.

FDA 510(k) clearance K132856 for HEARTWAY POWER WHEELCHAIR, Substantially Equivalent on 2014-07-15. Applicant: Heartway Medical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Heartway Medical Products Co., Ltd.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2013-09-12
Decision date: 2014-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, Taiwan, TW

Download summary PDF View on FDA.gov ↗

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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.