TensCare
- Primary DI
- 05033435120239
- Brand
- TensCare
- Company
- TENSCARE LIMITED
- Model
- Sports TENS 2
- Catalog number
- K-ST2
- Device description
- Sports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Sports TENS 2 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 fifty preset treatment programs and four manually adjustable programmes are available.
- Published
- 2023-08-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- OTC
- true
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K200694 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05033435120239 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05033435120239 | 05033435120239 | 5033435120239 |
GMDN Terms#
| Term | Definition |
|---|---|
| Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 569403736
- Device count
- 1
- Serial number
- 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 | |
| 05033435138920 | TensCare | Ova3 | K-OVA3 | 2024-07-24 |
| 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 |
| 05033435131419 | TensCare | Perfect EMS | K-PEMS | 2023-08-31 |
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| 00850087184045 | Homedics | FKA DISTRIBUTING CO., LLC | NUH | 2026-07-31 |
| 06924607703550 | Transcutaneous Electrical Nerve Stimulators | Shenzhen Kentro Medical Electronics Co.,Ltd | NUH | 2026-07-31 |
| 06971712726417 | Nourishnest | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-29 |
| 06971712726417 | Nourishnest | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-29 |
| 06971712725908 | MASTOGO | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-25 |
| 06971712725908 | MASTOGO | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-25 |
| 00850080988657 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-07-22 |
| 00850080988657 | AUVON | UAN HEALTHCARE LIMITED | NGX | 2026-07-22 |
| 06978146200117 | Sinrel | SHENZHEN SINREL TECH LTD | NUH | 2026-07-21 |
| 06978146200124 | Sinrel | SHENZHEN SINREL TECH LTD | NUH | 2026-07-21 |
| 00850085485090 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-07-16 |
| 00860015112446 | Doctor's Choice® | CLINICAL HEALTH SERVICES, INC. | NUH | 2026-07-14 |
| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-09 |
| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-09 |
| 00850080988572 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-07-03 |
| 00850080988572 | AUVON | UAN HEALTHCARE LIMITED | NGX | 2026-07-03 |
| 06971712727636 | ONENTECH | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-03 |
| 06971712727636 | ONENTECH | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-03 |
| 06978452680122 | AUVON | Shenzhen Jiantuo Electronics Co., Ltd | NUH | 2026-07-01 |
| 06978452680122 | AUVON | Shenzhen Jiantuo Electronics Co., Ltd | NGX | 2026-07-01 |
| 00850085485021 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NGX | 2026-06-26 |
| 00850085485021 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-06-26 |
| 00850085485038 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NGX | 2026-06-26 |
| 00850085485038 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-06-26 |
| 00850085485045 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-06-26 |
| 00850085485045 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NGX | 2026-06-26 |
| 00850085485007 | AVCOO | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-06-25 |
| 00850085485007 | AVCOO | Ansion Technology (GuangDong) Co. Ltd. | NGX | 2026-06-25 |