BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR— 510(k) K011701

Substantially Equivalent

Taiwan Armada Enterprise Co., Ltd.

FDA 510(k) clearance K011701 for BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR, Substantially Equivalent on 2001-06-22. Applicant: Taiwan Armada Enterprise Co., Ltd..

Clearance details

Applicant: Taiwan Armada Enterprise Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2001-06-01
Decision date: 2001-06-22
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.