HEARTWAY POWER MOBILITY SCOOTER, S9

Vehicle, Motorized 3-wheeled

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 Power Mobility Scooter, S9.

Pre-market Notification Details

Device IDK092154
510k NumberK092154
Device Name:HEARTWAY POWER MOBILITY SCOOTER, S9
ClassificationVehicle, Motorized 3-wheeled
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 CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-16
Decision Date2009-09-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719871230459 K092154 000

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