BIOTECH POWERED WHEELCHAIR, C650PW— 510(k) K011846

Substantially Equivalent

Roc Chinese-European Industrial Research Society

FDA 510(k) clearance K011846 for BIOTECH POWERED WHEELCHAIR, C650PW, Substantially Equivalent on 2002-01-18. Applicant: Roc Chinese-European Industrial Research Society.

Clearance details

Applicant: Roc Chinese-European Industrial Research Society
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2001-06-12
Decision date: 2002-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

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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.