Tenscare Kegelfit Pelvic Floor Exerciser K-KEGEL

GUDID 05033435132089

The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscl

TENSCARE LIMITED

Perineal orifice incontinence-control electrical stimulation system
Primary Device ID05033435132089
NIH Device Record Key52a1f9a7-1c8b-4c5a-8af7-5e81d0228b9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTenscare Kegelfit Pelvic Floor Exerciser
Version Model NumberKegelFit2
Catalog NumberK-KEGEL
Company DUNS569403736
Company NameTENSCARE LIMITED
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800 308 7390
Emailcompliance@tenscare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105033435132089 [Primary]

FDA Product Code

KPIStimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-19
Device Publish Date2018-06-18

Devices Manufactured by TENSCARE LIMITED

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05033435133796 - TensCare2023-10-12 Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bullet body collides with the ther
05033435120413 - TensCare2023-09-11 The KneeStim Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your knee, with an intended u
05033435000722 - TensCare2023-09-08 The iGlove Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your hands, with an intended us
05033435000739 - TensCare2023-09-08 The iSock Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your feet, with an intended use
05033435070039 - TensCare2023-09-08 The iTouch Sure 2 is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation

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