CoolTone

Stimulator, Muscle, Powered, For Muscle Conditioning

Zimmer MedizinSysteme GmbH

The following data is part of a premarket notification filed by Zimmer Medizinsysteme Gmbh with the FDA for Cooltone.

Pre-market Notification Details

Device IDK192940
501k NumberK192940
Device Name:CoolTone
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Zimmer MedizinSysteme GmbH Junkerstrasse 9 Neu-ulm,  DE 89231
ContactUte Hauss
CorrespondentScott Blood
Quality And Regulatory Services 151 Glensondale Road Stow,  MA  01775
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
501k Review PanelPhysical Medicine
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-18
Decision Date2019-11-15

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