TensCare
- Primary DI
- 05033435138784
- Brand
- TensCare
- Company
- TENSCARE LIMITED
- Model
- Cool Relief Electrodes 50X100
- Catalog number
- E-CR50100
- Device description
- The Cool Relief Electrode pads 50x100 mm are a pack of 4 reusable electrodes, with an intended use for the desired success of any stimulation (TENS or EMS). They are intended for a single user.
- Published
- 2024-11-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| GXY | Electrode, Cutaneous |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K132588 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05033435138784 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05033435138784 | 05033435138784 | 5033435138784 |
GMDN Terms#
| Term | Definition |
|---|---|
| Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 569403736
- Device count
- 1
- Lot or batch
- true
- Expiration 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 |
| 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 |
| 05033435120239 | TensCare | Sports TENS 2 | K-ST2 | 2023-08-31 |
| 05033435131419 | TensCare | Perfect EMS | K-PEMS | 2023-08-31 |
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| 08720791377595 | Neuroradium | Technomed Engineering B.V. | GXY | 2024-11-22 |
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