MyOnyx System

Stimulator, Muscle, Powered

Thought Technology Ltd.

The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Myonyx System.

Pre-market Notification Details

Device IDK213197
510k NumberK213197
Device Name:MyOnyx System
ClassificationStimulator, Muscle, Powered
Applicant Thought Technology Ltd. 5250 Ferrier, Suite 812 Montreal,  CA H4P 1L3
ContactSuresh Sugirtharaja
CorrespondentSuresh Sugirtharaja
Thought Technology Ltd. 5250 Ferrier, Suite 812 Montreal,  CA H4P 1L3
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2022-06-17

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