HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR

Wheelchair, Powered

HOME HEALTH TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Home Health Technology Co., Ltd. with the FDA for Home Health Power Wheelchair, Model Hc-200tr.

Pre-market Notification Details

Device IDK043376
510k NumberK043376
Device Name:HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR
ClassificationWheelchair, Powered
Applicant HOME HEALTH TECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 300
ContactKe-min Jen
CorrespondentKe-min Jen
HOME HEALTH TECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 300
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-08
Decision Date2005-01-10
Summary:summary

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