FDA.reportPublic FDA data

Lifecare

Primary DI
04719871183076
Brand
Lifecare
Company
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Model
PR-04H
Device description
Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode
Published
2016-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
KPIStimulator, Electrical, Non-Implantable, For Incontinence

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122194000LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBEEveryway Medical Instruments Co.,Ltd2013-04-04KPI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871183076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871183076047198711830764719871183076

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657383535
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871189108iSTIMiSTIM PR-13A2023-08-30
04719871184950iSTIMiSTIM PR-02-22023-08-25
04719871185049iSTIMiSTIM PR-03A2023-08-25
04719871189092iSTIMiSTIM PR-02A2023-08-25
04719871185605iSTIMA12025-12-03
04719871186015Pain ManagementHC-890A2025-12-03
04719871186039EverywayZ42025-12-03
04719871189276EverywaySG50D2023-08-30
04719871189283EverywaySG43682023-08-30
04719871189290EverywaySG601472023-08-30
04719871189306EverywaySG40402023-08-30
04719871189313EverywaySG75D2023-08-30
04719871189269EverywaySG57952023-08-25
04719871183656EverywaySG70902022-03-17
04719871184202EverywaySG50502022-03-17
04719871184219EverywaySG501002022-03-17
04719871184325EverywayS551052022-03-17
04719871184332EverywayS801202022-03-17
04719871185346EverywaySG50752022-03-17
04719871185131iSTIMiSTIM EV-9062023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942808259034Intrelief PFEEasyMed Instruments Co., Ltd.KPI2026-05-05
04719872333104LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
03830054238138QuantumStar, StarFormerFOTONA d.o.o.KPI2025-06-12
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
05033435135646TensCareTENSCARE LIMITEDKPI2023-10-24
04053815076711MFG-05Zimmer MedizinSysteme GmbHKPI2023-10-16
00860000860000Yarlap IRelevium Labs, Inc.KPI2023-10-07
00860000860031Yarlap IIRelevium Labs, Inc.KPI2023-10-07
05033435070039TensCareTENSCARE LIMITEDKPI2023-08-31
04719871189108iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-30
04719871184769LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184776LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184783LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184790LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25