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TensCare

FDA UDI

Class II (US FDA UDI)

by Tenscare Limited

Identity

Trade Name
TensCare FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
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. FDA UDI
Model / Reference
Ova3 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
K-OVA3 FDA UDI
Primary DI / UDI-DI
05033435138920 FDA UDI
510(k) Number
K230926 FDA UDI
FDA Product Code
NUH FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

TensCare by Tenscare Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K230926 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tenscare Limited

Sources (1)

  • FDA UDI 3c55d9a5-531b-4496-bbff-39e1c4a294c1 35 fields · synced May 30, 2026