KONMED /K-fit/pelvifine

GUDID 06970935830017

Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for wo

Shenzhen Konmed Technology Co., Ltd.

Perineal orifice incontinence-control electrical stimulation system
Primary Device ID06970935830017
NIH Device Record Keyaaa555d9-d8bc-4a96-8194-058a5941e618
Commercial Distribution StatusIn Commercial Distribution
Brand NameKONMED /K-fit/pelvifine
Version Model NumberKM518
Company DUNS544436531
Company NameShenzhen Konmed Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106970935830017 [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 Number3
Public Version Date2018-07-06
Device Publish Date2018-01-24

Devices Manufactured by Shenzhen Konmed Technology Co., Ltd.

06970935830482 - KONMED2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
06970935830499 - KONMED2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
06970935830642 - KONMED2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
06970935830659 - KONMED2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
06970935830666 - KONMED2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
06970935830673 - KONMED2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
06970935830680 - KONMED2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
06970935830697 - KONMED2024-03-13 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode

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