BIOTECH POWERED WHEELCHAIR, C650PW

Wheelchair, Powered

ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY

The following data is part of a premarket notification filed by Roc Chinese-european Industrial Research Society with the FDA for Biotech Powered Wheelchair, C650pw.

Pre-market Notification Details

Device IDK011846
510k NumberK011846
Device Name:BIOTECH POWERED WHEELCHAIR, C650PW
ClassificationWheelchair, Powered
Applicant ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO.58, FU-CHIUN STREET, Hsin-chu City,  TW
ContactJen Ke-min
CorrespondentJen Ke-min
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO.58, FU-CHIUN STREET, Hsin-chu City,  TW
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-12
Decision Date2002-01-18

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