Dr-Ho's Foot Pad Electrode

Electrode, Cutaneous

DRTV ASIA LTD

The following data is part of a premarket notification filed by Drtv Asia Ltd with the FDA for Dr-ho's Foot Pad Electrode.

Pre-market Notification Details

Device IDK151693
510k NumberK151693
Device Name:Dr-Ho's Foot Pad Electrode
ClassificationElectrode, Cutaneous
Applicant DRTV ASIA LTD 2ND BUILDING, JUNTUO INDUSTRY PARK, XINYE DADAO, NANCUN Panyu,  CN 511442
ContactMichael Ho
CorrespondentGuenter Ginsberg
MEDIA TRADE CORPORATION 11820 RED HIBISCUS DRIVE Bonita Springs,  FL  34135
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-23
Decision Date2015-10-09
Summary:summary

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