FDA.reportPublic FDA data

KONMED

Primary DI
06970935830666
Brand
KONMED
Company
Shenzhen Konmed Technology Co., Ltd.
Model
KM-506
Device description
Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
Published
2024-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
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
K233576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233576000Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)Shenzhen Konmed Technology Co., Ltd.2024-02-23KPI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970935830666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970935830666069709358306666970935830666

GMDN Terms#

Term, Definition table
TermDefinition
Perineal orifice incontinence-control electrical stimulation system probe, reusableAn invasive electrical conductor which is a component of a perineal orifice incontinence-control electrical stimulator intended for the treatment of urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor. It connects to an external pulse generator (not included) and is in the form of a cylinder-like probe with surface electrodes for insertion into the vagina and/or anus whereby therapy involves induction of Kegel-like contractions. It is intended for use in both the home (self-treatment) and healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544436531
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970935830529KONMED /PelvifineKM508B2025-09-30
06970935830710PelvifineKM5002025-02-18
06970935830536KONMED /PelvifineKM5302021-10-25
06970935830543KONMED /PelvifineKM5312021-10-25
06970935830482KONMEDKM-5022024-03-05
06970935830499KONMEDKM-5032024-03-05
06970935830642KONMEDKM-5042024-03-05
06970935830659KONMEDKM-5052024-03-05
06970935830673KONMEDKM-5072024-03-05
06970935830680KONMEDKM-50132024-03-05
06970935830697KONMEDKM-50182024-03-05
06970935830567KONMED /PelvifineKM530B2022-08-24
06970935830574KONMED /PelvifineKM531B2022-08-24
06970935830581KONMED /PelvifineKM5362022-08-24
06970935830598KONMED /PelvifineKM5372022-08-24
06970935830079KonmedKM-8032018-01-25
06970935830086KonmedKM-8082018-01-25
06970935830093KonmedKM-8012018-01-25
06970935830109KonmedKM-8022018-01-25
06970935830116KonmedKM-8062018-01-25

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
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
04719871184806LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25