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
510k 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-18
Decision Date2019-11-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04053815076698 K192940 000

Trademark Results [CoolTone]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COOLTONE
COOLTONE
88266308 not registered Live/Pending
Zeltiq Aesthetics, Inc.
2019-01-17

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