Katalyst Training System

Stimulator, Muscle, Powered, For Muscle Conditioning

Katalyst Inc.

The following data is part of a premarket notification filed by Katalyst Inc. with the FDA for Katalyst Training System.

Pre-market Notification Details

Device IDK190966
510k NumberK190966
Device Name:Katalyst Training System
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Katalyst Inc. 316 Occidental Ave. South Suite B300 Seattle,  WA  98104
ContactBjoern Woltermann
CorrespondentBjoern Woltermann
Katalyst Inc. 316 Occidental Ave. South Suite B300 Seattle,  WA  98104
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
510k Review PanelPhysical Medicine
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-12
Decision Date2020-02-03

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