Wireless TENS/EMS, Bruno, Aela

Stimulator, Nerve, Transcutaneous, Over-the-counter

ZMI Elecronics Ltd.

The following data is part of a premarket notification filed by Zmi Elecronics Ltd. with the FDA for Wireless Tens/ems, Bruno, Aela.

Pre-market Notification Details

Device IDK220997
510k NumberK220997
Device Name:Wireless TENS/EMS, Bruno, Aela
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant ZMI Elecronics Ltd. 6F-1, 286-4, Shin Ya Road Kaohsiung,  TW 806
ContactLawerence Liu
CorrespondentYuta Lee
ZMI Elecronics Ltd. 6F-1, 286-4, Shin Ya Road Kaohsiung,  TW 806
Product CodeNUH  
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-09-01

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