LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR

Stimulator, Muscle, Powered

SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.

The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Lt3000 Combo Stimulator, Lt3001 Tens Stimulatory, Lt3002 Ems Stimulator.

Pre-market Notification Details

Device IDK100117
510k NumberK100117
Device Name:LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
ClassificationStimulator, Muscle, Powered
Applicant SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. ESTAE XILIXIAOBAIMANG Nanshan District, Shenzhen,  CN 518108
ContactZhigang Zhao
CorrespondentMarc M Mouser
UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas,  WA  98607 -9526
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-01-15
Decision Date2010-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
80092237618550 K100117 000
80092237617515 K100117 000
80092237616679 K100117 000
80092237615900 K100117 000

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