Balego TENS Digital Edition With Accessories For Pain Relief (OTC)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Everyway Medical Instruments CO., LDT.

The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ldt. with the FDA for Balego Tens Digital Edition With Accessories For Pain Relief (otc).

Pre-market Notification Details

Device IDK181207
510k NumberK181207
Device Name:Balego TENS Digital Edition With Accessories For Pain Relief (OTC)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Everyway Medical Instruments CO., LDT. 3 Fl., No. 5, Lane 155, Sec.3 Beishen Rd. New Taipei City,  TW 22203
ContactPaul Hung
CorrespondentAaron Hage
DuVal & Associates 825 Nicollet Mall, Suite 1820 Minneapolis,  MN  55402
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-07
Decision Date2018-06-06
Summary:summary

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