JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP— 510(k) K062218

Substantially Equivalent

Jan Mao Industries Co., Ltd.

FDA 510(k) clearance K062218 for JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP, Substantially Equivalent on 2006-08-16. Applicant: Jan Mao Industries Co., Ltd..

Clearance details

Applicant: Jan Mao Industries Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2006-08-01
Decision date: 2006-08-16
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.