InTone®MV 5000000A1

GUDID 00851508007011

InToneMV

INCONTROL MEDICAL, LLC

Perineal orifice incontinence-control electrical stimulation system electrode
Primary Device ID00851508007011
NIH Device Record Keyad05b665-7316-45da-a2a3-613514a85412
Commercial Distribution StatusIn Commercial Distribution
Brand NameInTone®MV
Version Model Number5000000A1
Catalog Number5000000A1
Company DUNS052247990
Company NameINCONTROL MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com
Phone+1(262)373-0422
Emailinfo@incontrolmedical.com

Device Dimensions

Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch
Length51.4 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851508007011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPISTIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-20
Device Publish Date2016-10-03

Devices Manufactured by INCONTROL MEDICAL, LLC

00851508007103 - Attain2019-03-27 Attain
00851508007004 - InTone®2019-03-20 InTone
00851508007011 - InTone®MV2019-03-20InToneMV
00851508007011 - InTone®MV2019-03-20 InToneMV
00851508007028 - Apex®2019-03-20 Apex
00851508007035 - Apex®M2019-03-20 ApexM
00851508007042 - InTone® NASP2019-03-20 InTone NASP
00851508007059 - InTone®MV NASP2019-03-20 InToneMV-NASP
00851508007073 - InTone® by Viveve2019-03-20 InTone by Viveve

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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