VECTRA GENISYS VMS FR

Stimulator, Muscle, Powered

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Vectra Genisys Vms Fr.

Pre-market Notification Details

Device IDK062354
510k NumberK062354
Device Name:VECTRA GENISYS VMS FR
ClassificationStimulator, Muscle, Powered
Applicant ENCORE MEDICAL, L.P. 4717 ADAMS ROAD Hixson,  TN  37343
ContactMichael Treas
CorrespondentMichael Treas
ENCORE MEDICAL, L.P. 4717 ADAMS ROAD Hixson,  TN  37343
Product CodeIPF  
Subsequent Product CodeGZI
Subsequent Product CodeGZJ
Subsequent Product CodeHCC
Subsequent Product CodeIMG
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-14
Decision Date2007-01-26
Summary:summary

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