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 |
| 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 |
Trademark Results [TensCare]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENSCARE 79258286 not registered Live/Pending |
Tenscare Limited 2019-01-03 |
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