TensCare K-UNIFIT
GUDID 05033435136209
Unifit combines the treatment capabilities of a TENS device, an EMS or NMES device, and a relaxing massage stimulator in one unit. It sends a small and gentle stimulation (similar to your natural nerve impulses) to the muscles being treated via two or four auto-adhesive electrode pads, in order to help you to firm and tone your body. Unifit is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Unifit is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has preset treatment programs and manually adjustable programmes are available.
TENSCARE LIMITED
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 05033435136209 |
| NIH Device Record Key | 252d985b-f93a-4cb9-ad3e-6e50dd32a0bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TensCare |
| Version Model Number | Unifit |
| Catalog Number | K-UNIFIT |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05033435136209 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200694
FDA Product Code
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
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 | 2023-11-13 |
| Device Publish Date | 2023-11-03 |
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 |
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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