REVITIVE IX

Stimulator, Muscle, Powered

Actegy Ltd

The following data is part of a premarket notification filed by Actegy Ltd with the FDA for Revitive Ix.

Pre-market Notification Details

Device IDK123354
510k NumberK123354
Device Name:REVITIVE IX
ClassificationStimulator, Muscle, Powered
Applicant Actegy Ltd 555 13TH STREET, NW Washington,  DC  20004
ContactJohn J Smith
CorrespondentJohn J Smith
Actegy Ltd 555 13TH STREET, NW Washington,  DC  20004
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-31
Decision Date2013-06-28
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.