Data / Medical devices / United Kingdom / Tenscare Ltd.
Tenscare Ltd.: FDA-registered device maker in EPSOM Surrey, United Kingdom, 15 510(k) clearances
Tenscare Ltd. is registered with the FDA (registration 3003446042) in EPSOM Surrey, United Kingdom. It lists 8 device types. The FDA files 15 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003446042
- Address
- Painaway House, 9 Blenheim Road Longmead Business Park, EPSOM Surrey, United Kingdom, KT19 9BE
- Owner or operator
- TENSCARE LTD. (9046089)
- Roles
- Exporter to the US, Foreign private label distributor, Repackager or relabeler, Specification developer
- First device listed
- December 2, 2010
- Registered through
- 2026
- Brand names listed
- Back Electrode, Butterfly Electrode pads, Carbon Mesh Electrode pads 50X100 mm, Carbon Mesh Electrode pads 50X50 mm, Carbon Mesh Electrode pads 50x100mm, Circle Electrode pads 25mm dia, Cooling Electrode pads 50X100 mm, Cooling Electrode pads 50X50 mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Exporter to the US, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Foreign private label distributor, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 15, 2023 | K230926 | Ova+ (K-OVAP-USA) | NUH | Substantially Equivalent | Tenscare, Ltd. | accessdata.fda.gov |
| October 20, 2023 | K230983 | Unicare (K-UNICARE-USA) | KPI | Substantially Equivalent | Tenscare, Ltd. | accessdata.fda.gov |
| August 18, 2023 | K231053 | Unicare (K-UNICARE-USA) | NUH | Substantially Equivalent | Tenscare, Ltd. | accessdata.fda.gov |
| August 31, 2021 | K210448 | Adhesive Electrode | GXY | Substantially Equivalent | Shaoxing Yingtuo Healthcare Co., Ltd. | accessdata.fda.gov |
| June 4, 2021 | K200694 | Perfect EMS | NUH | Substantially Equivalent | Tenscare, Ltd. | accessdata.fda.gov |
| March 30, 2020 | K192640 | Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump | HGX | Substantially Equivalent | Guangzhou Yongyi Industrial Co., Ltd. | accessdata.fda.gov |
| November 1, 2019 | K191312 | Perfect PFE | KPI | Substantially Equivalent | Tenscare, Ltd. | accessdata.fda.gov |
| January 5, 2018 | K171721 | Electrodes with silver conductive | GXY | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd. | accessdata.fda.gov |
| December 21, 2015 | K151284 | Electric Double Breast Pumps | HGX | Substantially Equivalent | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | accessdata.fda.gov |
| April 20, 2015 | K142506 | TensCare KegelFit | KPI | Substantially Equivalent | Tenscare, Ltd. | accessdata.fda.gov |
| August 28, 2014 | K140168 | EASYSTIM TN28_OTC | NUH | Substantially Equivalent | Easymed Instruments Co., Ltd. | accessdata.fda.gov |
| November 22, 2013 | K132588 | ADHESIVE ELECTRODES | GXY | Substantially Equivalent | Top-Rank Health Care Equipment Co., Ltd. | accessdata.fda.gov |
| March 7, 2013 | K122476 | LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT | NUC | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| June 21, 2011 | K103698 | TENSCARE ITOUCH SURE MODEL ITS | KPI | Substantially Equivalent | Tenscare, Ltd. | accessdata.fda.gov |
| February 9, 2009 | K082377 | TENSCARE ITOUCH MODEL(S) EASY AND PLUS | GZJ | Substantially Equivalent | Tenscare, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Lubricant, Personal
- All makers of Electrode, Cutaneous
- All makers of Pump, Breast, Powered
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
Updated December 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.