KARMA POWER WHEELCHAIR, MODEL KP-25— 510(k) K041678

Substantially Equivalent

Karma Medical Products Co., Ltd.

FDA 510(k) clearance K041678 for KARMA POWER WHEELCHAIR, MODEL KP-25, Substantially Equivalent on 2004-07-23. Applicant: Karma Medical Products Co., Ltd..

Clearance details

Applicant: Karma Medical Products Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2004-06-21
Decision date: 2004-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

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.