TensCare Ltd

TensCare Ltd specialises in transcutaneous electrical nerve stimulation (TENS) devices and related electrodes. Their portfolio includes portable TENS units like the Perfect EMS and TENS One, designed for pain relief, as well as disposable electrodes for targeted applications such as breast, knee, and general muscle stimulation. Some products, like the Cool Relief Electrodes, incorporate additional features like cooling for enhanced therapy.

TensCare Ltd is based in the United Kingdom (GB). Their devices are intended for use in regions where they comply with local regulatory requirements, including the European Union and the United States. Compliance is demonstrated through listings in the EUDAMED database for EU devices and the FDA’s 510(k) registry for US-market products.

TensCare Ltd’s devices are listed in the EUDAMED database under the EU Medical Device Regulations, reflecting their classification as Class I, Class II, and Class IIa products. Additionally, their devices appear in the FDA’s 510(k) registry, indicating compliance with US regulatory requirements for electrical stimulation and electrode-based therapies.

TensCare Ltd’s devices are classified under the EU Medical Device Regulations as Class I (low-risk devices), Class II (moderate-risk devices requiring additional safety measures), and Class IIa (a subset of Class II with specific risk controls). The classification determines regulatory pathways, such as conformity assessment procedures, and ensures appropriate oversight based on the device’s intended use and potential risks.