Hi-Dow Wireless TENS/EMS System (Model HD-SN)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Hi-Dow International, Inc.

The following data is part of a premarket notification filed by Hi-dow International, Inc. with the FDA for Hi-dow Wireless Tens/ems System (model Hd-sn).

Pre-market Notification Details

Device IDK163393
510k NumberK163393
Device Name:Hi-Dow Wireless TENS/EMS System (Model HD-SN)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Hi-Dow International, Inc. 2555 Metro Blvd Maryland Heights,  MO  63043
ContactEric Chen
CorrespondentSchevon G. Salmon
Benjamin L. England & Associates, LLC 810 Landmark Drive, Suite 126 Glen Burnie,  MD  21061
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-02
Decision Date2017-08-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851640007467 K163393 000
00810093080137 K163393 000
00810093080144 K163393 000
00782944027014 K163393 000
00851640007399 K163393 000
00851640007405 K163393 000
00851640007412 K163393 000
00851640007429 K163393 000
00851640007436 K163393 000
00810093080205 K163393 000

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