TensCare

Primary DI
05033435138920
Brand
TensCare
Company
TENSCARE LIMITED
Model
Ova3
Catalog number
K-OVA3
Device description
The Ova3 is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle. The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS).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 these self-adhesive electrodes to superficial nerves. The unit is intended for home use by the patient and is designed with simplicity and ease of use in mind. It has four preset treatment Modes. The level of electrical stimulation of Ova3 is easily controlled by the end user using manual, push-button controls.The new device Ova3 uses the same technical principle and substantially equivalent stimulation parameters to predicate devices marketed Livia (K183110) and/or Perfect EMS (K200694)The Ova3 uses a rechargeable Li-Ion polymer battery and a custom TENS. The Ova3 is supplied with adhesive electrode gel pads.
Published
2024-07-24
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230926000Ova+ (K-OVAP-USA)Tenscare, Ltd.2023-12-15NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05033435138920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033435138920050334351389205033435138920

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
569403736
Device count
1
Serial number
true
Manufacturing date on label
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
05033435134090TensCareOva+K-OVAP-USA2024-01-16
05033435136209TensCareUnifitK-UNIFIT2023-11-03
05033435135646TensCareUnicareK-UNICARE2023-10-24
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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