KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105— 510(k) K062309

Substantially Equivalent

Karma Medical Products Co., Ltd.

FDA 510(k) clearance K062309 for KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105, Substantially Equivalent on 2006-10-10. Applicant: Karma Medical Products Co., Ltd..

Clearance details

Applicant: Karma Medical Products Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2006-08-08
Decision date: 2006-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.