EMPI MULTIDAY TENS DISPOSABLE ELECTRODE

Electrode, Cutaneous

EMPI

The following data is part of a premarket notification filed by Empi with the FDA for Empi Multiday Tens Disposable Electrode.

Pre-market Notification Details

Device IDK890614
510k NumberK890614
Device Name:EMPI MULTIDAY TENS DISPOSABLE ELECTRODE
ClassificationElectrode, Cutaneous
Applicant EMPI 1275 GREY FOX RD. St Paul,  MN  55112
ContactStacy Mattson
CorrespondentStacy Mattson
EMPI 1275 GREY FOX RD. St Paul,  MN  55112
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-07
Decision Date1989-03-16

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