FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR

Stimulator, Muscle, Powered

FAMIDOC TECHNOLOGY CO., LTD

The following data is part of a premarket notification filed by Famidoc Technology Co., Ltd with the FDA for Fdes100(tens And Ems Stimulator, Fdes102(ed402) Tens Stimulator.

Pre-market Notification Details

Device IDK113010
510k NumberK113010
Device Name:FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
ClassificationStimulator, Muscle, Powered
Applicant FAMIDOC TECHNOLOGY CO., LTD East 2/F,Zhixiang Building,71 BLOCK BAOAN DISTRICT Shenzhen,  CN 518101
ContactCao Liang
CorrespondentCao Liang
FAMIDOC TECHNOLOGY CO., LTD East 2/F,Zhixiang Building,71 BLOCK BAOAN DISTRICT Shenzhen,  CN 518101
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-11
Decision Date2012-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970389634018 K113010 000
06970389634025 K113010 000
06970389634032 K113010 000
00818218024806 K113010 000
00818218024813 K113010 000
M368GFDF52 K113010 000
00854314007220 K113010 000
00854314007237 K113010 000
06970389630096 K113010 000
06970389630102 K113010 000
06970389634001 K113010 000

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