TensCare K-KT

GUDID 05033435134021

The Kegel Toner is a powered muscle stimulator used for strengthening the pelvic floor muscles. The Kegel Toner is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.

TENSCARE LIMITED

Perineal orifice incontinence-control electrical stimulation system

• Primary Device ID: 05033435134021
• NIH Device Record Key: d5bbc753-8098-489b-af97-0a51287379bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TensCare
• Version Model Number: Kegel Toner
• Catalog Number: K-KT
• Company DUNS: 569403736
• Company Name: TENSCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800 308 7390
• Email: compliance@tenscare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05033435134021 [Primary]

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-08
• Device Publish Date: 2019-06-30

On-Brand Devices [TensCare]

• 05033435134021: The Kegel Toner is a powered muscle stimulator used for strengthening the pelvic floor muscles.
• 05033435134045: TENS One is a TENS device which is commonly used to provide relief from pain associated with sor
• 05033435134458: The Sure + is intended to provide electrical stimulation and neuromuscular re-education for the
• 05033435136483: Sports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and facilit
• 05033435136490: The Nouri Digital Electric Breast Pump is a powered breast pump to be used by lactating women to
• 05033435135776: The Nouri Digital Electric Breast Pump is a powered breast pump to be used by lactating women to
• 05033435134199: The Butterfly Electrode pads, is a pack of 2 reusable electrodes, with an intended use for the d
• 05033435133185: The Face electrode pads are a pack of 4 reusable electrodes, with an intended use for the desire
• 05033435133147: The Joint Electrode pad, is a pack of 1 reusable electrode designed for joints, with an intended
• 05033435130979: The Ova+ Electrode pads 90x50 mm are a pack of 2 reusable electrodes, with an intended use for t
• 05033435000647: The Circle Electrode pads 25mm dia, is a pack of 10 reusable electrodes, with an intended use fo
• 05033435000517: The Carbon Mesh Electrode pads 50x100mm, is a pack of 4 reusable electrodes, with an intended us
• 05033435000500: The Carbon Mesh Electrode pads 50x50 mm, is a pack of 4 reusable electrodes, with an intended us
• 00533435133796: Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bu
• 05033435136995: The Oko Eye Massager uses air pressure, vibration and hot compress cycle technology to massage t
• 05033435136759: Form is a variant of the Perfect EMS medical device. It has one programme identical to one progr
• 05033435000616: The iSock Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on
• 05033435000609: The iGlove Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on
• 05033435131419: Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitat
• 05033435120239: Sports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and facilit
• 05033435070039: The iTouch Sure 2 is a powered muscle stimulator used for strengthening the pelvic floor muscles
• 05033435000739: The iSock Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on
• 05033435000722: The iGlove Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on
• 05033435120413: The KneeStim Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing
• 05033435133796: Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bu
• 05033435135646: The Unicare is a powered muscle stimulator used for strengthening the pelvic floor muscles. It s
• 05033435136209: Unifit combines the treatment capabilities of a TENS device, an EMS or NMES device, and a relaxi
• 05033435134090: The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide
• 05033435138920: The Ova3 is a non-invasive small and convenient unit that can be worn under clothing to provide
• 05033435136933: Form Duo is a variant of the Perfect EMS medical device and is identical to the Form unit but co
• 05033435139729: The Neck Electrode is a reusable electrode, with an intended use for the desired success of any
• 05033435139712: The Knee Electrode is a pack of 2 reusable electrodes, with an intended use for the desired succ
• 05033435139705: The Back Electrode is a reusable electrodes, with an intended use for the desired success of any
• 05033435139156: TheCarbon Mesh Electrode pads 50X100 mm are a pack of 4 reusable electrodes, with an intended us
• 05033435139132: The Carbon Mesh Electrode pads 50X50 mm are a pack of 4 reusable electrodes, with an intended us
• 05033435139118: The Hypoallergenic Electrode pads 50x50 mm are a pack of 4 reusable electrodes, with an intended
• 05033435138784: The Cool Relief Electrode pads 50x100 mm are a pack of 4 reusable electrodes, with an intended u
• 05033435138777: The Cool Relief Electrode pads 50x50 mm are a pack of 4 reusable electrodes, with an intended us