HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1

Wheelchair, Powered

HEARTWAY MEDICAL PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Attendant-controlled Power Chair, Tc1.

Pre-market Notification Details

Device IDK071006
510k NumberK071006
Device Name:HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
ClassificationWheelchair, Powered
Applicant HEARTWAY MEDICAL PRODUCTS CO., LTD. NO.58, FU-CHIUN ST. Hsin-chu City,  TW 408
ContactKe-min Jen
CorrespondentKe-min Jen
HEARTWAY MEDICAL PRODUCTS CO., LTD. NO.58, FU-CHIUN ST. Hsin-chu City,  TW 408
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-09
Decision Date2007-05-21
Summary:summary

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