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 |
|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K230926 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05033435138920 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05033435138920 | 05033435138920 | 5033435138920 |
GMDN Terms#
| Term | Definition |
|---|---|
| Analgesic transcutaneous electrical nerve stimulation system | An 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 |
|---|
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 | Catalog | Published |
|---|---|---|---|---|
| 05033435134403 | TensCare | Kegel Fit 2 | K-KEGEL2 | 2024-11-18 |
| 05033435138777 | TensCare | Cool Relief Electrodes 50X50 | E-CR5050 | 2024-11-06 |
| 05033435138784 | TensCare | Cool Relief Electrodes 50X100 | E-CR50100 | 2024-11-06 |
| 05033435139118 | TensCare | Hypoallergenic Electrodes | E-TRBG | 2024-11-06 |
| 05033435139132 | TensCare | Carbon Mesh Electrode pads 50X50 mm | E-TR5050 | 2024-11-06 |
| 05033435139156 | TensCare | Carbon Mesh Electrode pads 50X100 mm | E-TR50100 | 2024-11-06 |
| 05033435139705 | TensCare | Back Electrode | E-TRALBA | 2024-11-06 |
| 05033435139712 | TensCare | Knee Electrode | K-TRALKN | 2024-11-06 |
| 05033435139729 | TensCare | Neck Electrode | E-TRALNE | 2024-11-06 |
| 05033435136933 | TensCare | Form Duo | 2024-07-25 | |
| 05033435134090 | TensCare | Ova+ | K-OVAP-USA | 2024-01-16 |
| 05033435136209 | TensCare | Unifit | K-UNIFIT | 2023-11-03 |
| 05033435135646 | TensCare | Unicare | K-UNICARE | 2023-10-24 |
| 05033435133796 | TensCare | Shockwave | K-SHOCKWAVE | 2023-06-08 |
| 05033435120413 | TensCare | KneeStim | K-KNEE | 2023-09-01 |
| 05033435000722 | TensCare | iGlove Large | K-GL-L | 2023-08-31 |
| 05033435000739 | TensCare | iSock Large | K-SK-L | 2023-08-31 |
| 05033435070039 | TensCare | iTouch Sure | K-ITS | 2023-08-31 |
| 05033435120239 | TensCare | Sports TENS 2 | K-ST2 | 2023-08-31 |
| 05033435131419 | TensCare | Perfect EMS | K-PEMS | 2023-08-31 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06978452680085 | AUVON | Shenzhen Jiantuo Electronics Co., Ltd | NUH | 2026-06-03 |
| 06978452680092 | AUVON | Shenzhen Jiantuo Electronics Co., Ltd | NUH | 2026-06-03 |
| 06978452680108 | NURSAL | Shenzhen Jiantuo Electronics Co., Ltd | NUH | 2026-06-03 |
| 06971712722075 | MASTOGO | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-06-02 |
| 06971712726943 | MASTOGO | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-05-30 |
| 06971712722990 | Sality | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-05-28 |
| 03770018808086 | actiTENS | SUBLIMED | NUH | 2026-05-27 |
| 03770018808093 | actiTENS | SUBLIMED | NUH | 2026-05-27 |
| 03770018808109 | actiTENS | SUBLIMED | NUH | 2026-05-27 |
| 03770018808116 | actiTENS | SUBLIMED | NUH | 2026-05-27 |
| 03770018808253 | actiTENS Mini | SUBLIMED | NUH | 2026-05-27 |
| 03770018808260 | actiTENS Mini | SUBLIMED | NUH | 2026-05-27 |
| 00850080988411 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-05-06 |
| 00194346404155 | Equate | WAL-MART STORES, INC. | NUH | 2026-05-01 |
| 00850080988381 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-04-29 |
| 00850080988398 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-04-29 |
| 00850080988404 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-04-29 |
| 00850044118762 | iHealth | iHealth Labs Inc. | NUH | 2026-04-16 |
| 00850080988145 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-03-23 |
| 00850080988138 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-03-19 |
| 00850016867209 | Pixie Cup | Pixie Cup LLC | NUH | 2025-11-05 |
| 00810140062680 | RENPHO | Joicom Corporation | NUH | 2025-10-20 |
| 00810140062697 | RENPHO | Joicom Corporation | NUH | 2025-10-20 |
| 00810113683782 | ManaRecovery Stimulation System | Manamed, Inc. | NUH | 2025-10-03 |
| 00810113683799 | ManaRecovery Stimulation System Electrode Pad | Manamed, Inc. | NUH | 2025-10-03 |
| 00092237621967 | TwinStim | Drive Devilbiss Healthcare | NUH | 2025-09-29 |
| 00850073128183 | AVCOO | ADP HEALTH LIMITED | NUH | 2025-09-19 |
| 00850073128190 | AVCOO | ADP HEALTH LIMITED | NUH | 2025-09-19 |
| 00850073128169 | AVCOO | ADP HEALTH LIMITED | NUH | 2025-09-18 |
| 00810113683485 | ManaFlexx 2 Electrodes - 4 electrodes | Manamed, Inc. | NUH | 2025-09-11 |