InTone

Stimulator, Electrical, Non-implantable, For Incontinence

INCONTROL MEDICAL, LLC.

The following data is part of a premarket notification filed by Incontrol Medical, Llc. with the FDA for Intone.

Pre-market Notification Details

Device IDK150180
510k NumberK150180
Device Name:InTone
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant INCONTROL MEDICAL, LLC. 3225 GATEWAY ROAD, STE. 250 Brookfield,  WI  53045
ContactJessica Andreshak
CorrespondentJessica Andreshak
INCONTROL MEDICAL, LLC. 3225 GATEWAY ROAD, STE. 250 Brookfield,  WI  53045
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-27
Decision Date2015-03-16
Summary:summary

Trademark Results [InTone]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTONE
INTONE
85263563 4206932 Live/Registered
InControl Medical, LLC
2011-03-10
INTONE
INTONE
75035345 2102073 Live/Registered
Stamina Products, Inc.
1995-12-21

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