FDA.reportPublic FDA data

KONMED /K-fit/pelvifine

Primary DI
06970935830017
Brand
KONMED /K-fit/pelvifine
Company
Shenzhen Konmed Technology Co., Ltd.
Model
KM518
Device description
Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for women. Our principle aim is to design a product to give women the opportunity to exercise their muscles, strengthen weak muscles and nerve fibres in a compact, easy to use device - we also wanted the device to be able to be versatile enough so that as a woman achieve greater muscle control, with high levels of functional use, are sensibly priced, compact and user friendly.
Published
2018-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K163288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163288000Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.2018-01-18KPI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970935830017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970935830017069709358300176970935830017

GMDN Terms#

Term, Definition table
TermDefinition
Perineal orifice incontinence-control electrical stimulation systemAn assembly of battery-powered devices designed to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles of the pelvic floor. It consists of a pair of electrodes on a plug or pessary, and a pulse generator; it does not function by remote control. The plug or pessary is inserted into the rectum and/or the vagina to stimulate the pelvic floor muscles inducing Kegel-like contractions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544436531
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
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
06970935830666KONMEDKM-5062024-03-05
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

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