FOCUS MODEL 795 UNIT

Stimulator, Nerve, Transcutaneous, For Pain Relief

EMPI

The following data is part of a premarket notification filed by Empi with the FDA for Focus Model 795 Unit.

Pre-market Notification Details

Device IDK951951
510k NumberK951951
Device Name:FOCUS MODEL 795 UNIT
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant EMPI 1275 GREY FOX RD. St Paul,  MN  55112
ContactStacey Mattson
CorrespondentStacey Mattson
EMPI 1275 GREY FOX RD. St Paul,  MN  55112
Product CodeGZJ  
Subsequent Product CodeGZI
Subsequent Product CodeIPF
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-26
Decision Date1996-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B36711001L00 K951951 000

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