MAXPOWER RELIEF

Stimulator, Nerve, Transcutaneous, Over-the-counter

OMRON HEALTHCARE, INC.

The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Maxpower Relief.

Pre-market Notification Details

Device IDK141978
510k NumberK141978
Device Name:MAXPOWER RELIEF
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant OMRON HEALTHCARE, INC. 24301 WOODSAGE DR. Bonita Springs,  FL  34134
ContactPaul Dryden
CorrespondentPaul Dryden
OMRON HEALTHCARE, INC. 24301 WOODSAGE DR. Bonita Springs,  FL  34134
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-21
Decision Date2014-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00073796630294 K141978 000
00073796330323 K141978 000
00073796303235 K141978 000

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