FDA.reportPublic FDA data

InTone®

Primary DI
00851508007004
Brand
InTone®
Company
INCONTROL MEDICAL, LLC
Model
2000001A1
Catalog number
2000001A1
Device description
InTone
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIRPERINEOMETER
KPISTIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIRPerineometerObstetrics/Gynecology2
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851508007004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851508007004008515080070048515080070040851508007004

GMDN Terms#

Term, Definition table
TermDefinition
Perineal orifice incontinence-control electrical stimulation system electrodeA device used in a nonimplantable incontinence-control electrical stimulation system for the treatment of urinary and/or faecal incontinence through the application of electrical stimuli to the muscles of the pelvic floor, inducing Kegel-like contractions. It is a probe-like lead with a plug at the distal end where the electrodes, typically having both a negative and positive terminal, are situated; it may be inserted into the anus and/or the vagina. The proximal end has a connector to the generator. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius54 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(262)373-0422info@incontrolmedical.com

Regulatory Flags#

DUNS number
052247990
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851508007028Apex®3000000A13000000A12016-10-03
00851508007035Apex®M3100000A13100000A12016-10-03
00851508007097Apex®M by Viveve3100000A43100000A42017-07-28
00851508007103Attain3200000A13200000A12019-03-19
00851508007011InTone®MV5000000A15000000A12016-10-03
00851508007042InTone® NASP2000001A1-NASP2000001A1-NASP2016-10-03
00851508007059InTone®MV NASP5000000A1-NASP5000000A1-NASP2016-10-03
00851508007073InTone® by Viveve2000001A42000001A42017-07-28
00851508007080InTone®MV by Viveve5000000A45000000A42017-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942808259034Intrelief PFEEasyMed Instruments Co., Ltd.KPI2026-05-05
00864124000137Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.HIR2026-04-23
04719872333104LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333104LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
03830054238138QuantumStar, StarFormerFOTONA d.o.o.KPI2025-06-12
00810138370834DeliceBlush NoveltiesHIR2025-03-13
00819835024125WellnessBlush NoveltiesHIR2025-01-28
05033435134403TensCareTENSCARE LIMITEDKPI2024-11-18
G680LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceBLISSCO MEDICAL DEVICE LIMITEDKPI2024-11-14
LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceBLISSCO MEDICAL DEVICE LIMITEDKPI2024-11-14
03830054237728StarFormerFOTONA d.o.o.KPI2024-07-30
00092237626047Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
00092237626054Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
06970935830482KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830499KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830642KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830659KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830666KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830673KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830680KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830697KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
03770014642486Hinge Health Pelvic Trainer by PerifitX6 INNOVATIONSHIR2024-01-15
03770014642196Perifit Care+X6 INNOVATIONSHIR2024-01-04
05033435135646TensCareTENSCARE LIMITEDKPI2023-10-24
04053815076711MFG-05Zimmer MedizinSysteme GmbHKPI2023-10-16