SupaChair Powered Wheelchair

Wheelchair, Powered

Eurogreen International Inc.

The following data is part of a premarket notification filed by Eurogreen International Inc. with the FDA for Supachair Powered Wheelchair.

Pre-market Notification Details

Device IDK173315
510k NumberK173315
Device Name:SupaChair Powered Wheelchair
ClassificationWheelchair, Powered
Applicant Eurogreen International Inc. No. 48, Lane 220, Sec 1, Fu-Zun Rd., Yuan-Lin Township Chang-hua County,  CN 51055
ContactDavid Hsieh
CorrespondentDavid Hsieh
Eurogreen International Inc. No. 48, Lane 220, Sec 1, Fu-Zun Rd., Yuan-Lin Township Chang-hua County,  CN 51055
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-19
Decision Date2018-02-13
Summary:summary

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