BIOTECH B990K VIVI WHEELCHAIR— 510(k) K014198

Substantially Equivalent

Taiwan Armada Enterprise Co., Ltd.

FDA 510(k) clearance K014198 for BIOTECH B990K VIVI WHEELCHAIR, Substantially Equivalent on 2002-02-01. Applicant: Taiwan Armada Enterprise Co., Ltd..

Clearance details

Applicant: Taiwan Armada Enterprise Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2001-12-21
Decision date: 2002-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

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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.