888 WNLE POWERED WHEELCHAIR

Wheelchair, Powered

PIHSIANG MACHINERY MFG. CO., LTD.

The following data is part of a premarket notification filed by Pihsiang Machinery Mfg. Co., Ltd. with the FDA for 888 Wnle Powered Wheelchair.

Pre-market Notification Details

Device IDK142027
510k NumberK142027
Device Name:888 WNLE POWERED WHEELCHAIR
ClassificationWheelchair, Powered
Applicant PIHSIANG MACHINERY MFG. CO., LTD. 21184 FIGUEROA ST. Carson,  CA  90745
ContactDavid Lin
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York,  NY  10111
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-07-25
Decision Date2014-10-07
Summary:summary

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