Mytens Model: BW-TSX

Stimulator, Nerve, Transcutaneous, Over-the-counter

Bewell Connect Corp.

The following data is part of a premarket notification filed by Bewell Connect Corp. with the FDA for Mytens Model: Bw-tsx.

Pre-market Notification Details

Device IDK171026
510k NumberK171026
Device Name:Mytens Model: BW-TSX
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Bewell Connect Corp. Suite 410, 185 Alewife Brook Parkway Cambridge,  MA  02138
ContactJacob Chen
CorrespondentJacob Chen
Bewell Connect Corp. Suite 410, 185 Alewife Brook Parkway Cambridge,  MA  02138
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-05
Decision Date2017-11-01

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