JKH Stimulator Plus

Stimulator, Nerve, Transcutaneous, Over-the-counter

JKH USA, LLC

The following data is part of a premarket notification filed by Jkh Usa, Llc with the FDA for Jkh Stimulator Plus.

Pre-market Notification Details

Device IDK182203
510k NumberK182203
Device Name:JKH Stimulator Plus
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant JKH USA, LLC 1142 S. Diamond Bar Blvd, #861 Diamond Bar,  CA  91765
ContactBill Quanqin Dai
CorrespondentBill Quanqin Dai
JKH USA, LLC 1142 S. Diamond Bar Blvd, #861 Diamond Bar,  CA  91765
Product CodeNUH  
Subsequent Product CodeGZJ
Subsequent Product CodeIPF
Subsequent Product CodeIRT
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-15
Decision Date2019-03-14

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