Prelivia

Stimulator, Muscle, Powered

Rehabtronics Inc.

The following data is part of a premarket notification filed by Rehabtronics Inc. with the FDA for Prelivia.

Pre-market Notification Details

Device IDK210979
510k NumberK210979
Device Name:Prelivia
ClassificationStimulator, Muscle, Powered
Applicant Rehabtronics Inc. #4352, 10230 Jasper Avenue Edmonton,  CA T5j 4p6
ContactMike Pearson
CorrespondentMike Pearson
Rehabtronics Inc. #4352, 10230 Jasper Avenue Edmonton,  CA T5j 4p6
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-01
Decision Date2021-05-13

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