TensCare

Primary DI
05033435135646
Brand
TensCare
Company
TENSCARE LIMITED
Model
Unicare
Catalog number
K-UNICARE
Device description
The Unicare is a powered muscle stimulator used for strengthening the pelvic floor muscles.It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal probe with stainless steel electrodes. These signals make your pelvic floor muscles contract. If you have forgotten how to contract them, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Unicare can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. Additionally, the Unicare offers drug-free relief from period pain.
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KPIStimulator, Electrical, Non-Implantable, For Incontinence
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230983000
K231053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230983000Unicare (K-UNICARE-USA)Tenscare, Ltd.2023-10-20KPI
K231053000Unicare (K-UNICARE-USA)Tenscare, Ltd.2023-08-18NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05033435135646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033435135646050334351356465033435135646

GMDN Terms#

Term, Definition table
TermDefinition
Perineal orifice incontinence-control electrical stimulation system, home-useA device or device assembly available for use by a patient/layperson outside a clinical setting designed to treat urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It consists of an electrically-powered external pulse generator/biofeedback unit with controls (e.g., hand-held remote control) intended for wired or wireless connection to a cylinder-like probe with surface electrodes designed to be inserted into the vagina and/or anus; the probe may be included in the device assembly. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
569403736
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05033435134403TensCareKegel Fit 2K-KEGEL22024-11-18
05033435138777TensCareCool Relief Electrodes 50X50E-CR50502024-11-06
05033435138784TensCareCool Relief Electrodes 50X100E-CR501002024-11-06
05033435139118TensCareHypoallergenic ElectrodesE-TRBG2024-11-06
05033435139132TensCareCarbon Mesh Electrode pads 50X50 mmE-TR50502024-11-06
05033435139156TensCareCarbon Mesh Electrode pads 50X100 mmE-TR501002024-11-06
05033435139705TensCareBack ElectrodeE-TRALBA2024-11-06
05033435139712TensCareKnee ElectrodeK-TRALKN2024-11-06
05033435139729TensCareNeck ElectrodeE-TRALNE2024-11-06
05033435136933TensCareForm Duo2024-07-25
05033435138920TensCareOva3K-OVA32024-07-24
05033435134090TensCareOva+K-OVAP-USA2024-01-16
05033435136209TensCareUnifitK-UNIFIT2023-11-03
05033435133796TensCareShockwaveK-SHOCKWAVE2023-06-08
05033435120413TensCareKneeStimK-KNEE2023-09-01
05033435000722TensCareiGlove LargeK-GL-L2023-08-31
05033435000739TensCareiSock LargeK-SK-L2023-08-31
05033435070039TensCareiTouch SureK-ITS2023-08-31
05033435120239TensCareSports TENS 2K-ST22023-08-31
05033435131419TensCarePerfect EMSK-PEMS2023-08-31

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