Question 1

What types of medical devices does TensCare Ltd manufacture?

Accepted Answer

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.

Question 2

Where is TensCare Ltd based, and where are their devices used?

Accepted Answer

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.

Question 3

Which regulatory registries list TensCare Ltd’s devices?

Accepted Answer

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.

Question 4

How are TensCare Ltd’s devices classified under EU regulations?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Perfect EMS	K-PEMS	EUDAMED	Class IIa	Active
Perfect mama+	K-PM+	EUDAMED	Class IIa	Active
Press Stud Electrodes	E-ST	EUDAMED	Class I	Active
New mamaTENS Electrodes	E-CM50100MT-NEW	EUDAMED	Class I	Active
50x100mm Cool Relief Electrodes	E-CR50100	EUDAMEDFDA UDI	Class I	Active
Alivia	K-ALIVIA	EUDAMED	Class IIa	Active
TENS One	K-TENSONE	EUDAMEDFDA UDI	Class IIa	Active
Unifit	K-UNIFIT	EUDAMEDFDA UDI	Class IIa	Active
Knee Electrode	E-TRALKN	EUDAMEDFDA UDI	Class I	Active
50x50mm Electrode	E-CM5050	EUDAMEDFDA UDI	Class I	Active
Breast Electrodes	E-CM60130	EUDAMED	Class I	Active
Elise 2 Lead Wire	L-ELGR	EUDAMED	Class I	Active
Tenscare Ultima Nms/Ems	K023997	FDA 510(k)	Class II	Active
Ova+ (K-OVAP-USA)	K230926	FDA 510(k)	Class II	Active
Tenscare Itouch Sure Model Its	K103698	FDA 510(k)	Class II	Active
Ultima Tens Xl-A1	K020846	FDA 510(k)	Class II	Active
Tens Care, Model Xl-Y3	K011543	FDA 510(k)	Class II	Active
Tenscare, Model Tens Xl-2	K003591	FDA 510(k)	Class II	Active
Unicare (K-UNICARE-USA)	K230983	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Unipro (K-UNIPRO-US)	K232441	FDA 510(k)	Class II	Active
TensCare KegelFit	K142506	FDA 510(k)	Class II	Active
Tenscare Itouch Model(s) Easy And Plus	K082377	FDA 510(k)	Class II	Active
Unicare (K-UNICARE-USA)	K231053	FDA 510(k)	Class II	Active
50x50mm Electrode	E-TR5050	EUDAMEDFDA UDI	Class I	Active
iTouch Sure 2 (ES FR DE IT)	K-ITS (ES FR DE IT)	EUDAMED	Class IIa	Active
MYND Gel Pad - Refill x3 UK	E-MYND	EUDAMED	Class I	Active
100x180mm Electrode	E-CM100180	EUDAMED	Class I	Active
50x50mm Value Electrodes	E-CM5050V	EUDAMED	Class I	Active
iTouch Sure 2	K-ITS-GO	EUDAMED	Class IIa	Active
Neck Electrode	E-TRALNE	EUDAMEDFDA UDI	Class I	Active
L-CPT Lead	L-CPT	EUDAMED	Class I	Active
Butterfly Electrodes	E-BF155	EUDAMEDFDA UDI	Class I	Active
Liberty Fit Probe	X-PR13	EUDAMED	Class IIa	Active
50x100mm Electrode	E-CM50100	EUDAMEDFDA UDI	Class I	Active
Pelvi+	K-PELVI	EUDAMED	Class IIa	Active
Back Electrode	E-TRALBA	EUDAMEDFDA UDI	Class I	Active
iTouch Sure	K-ITS	EUDAMEDFDA UDI	Class IIa	Active
Blue Gel Electrodes 50x50mm	E-TRBG	EUDAMEDFDA UDI	Class I	Active
Electrodes 25mm dia.	E-CM25	EUDAMEDFDA UDI	Class I	Active
Ova Lead Wire	L-OVAPLUS	EUDAMED	Class I	Active
iSock Large	K-SOCK-L	EUDAMEDFDA UDI	Class I	Active
Qalm UK	K-QALM	EUDAMED	Class IIa	Active
Perfect EMS	K-PEMS	EUDAMEDFDA UDI	Class IIa	Active
Sure PRO	K-SP	EUDAMED	Class IIa	Active
Elise 2	K-EL2	EUDAMED	Class IIa	Active
Qalm Fr/It/De/Nl	K-QALM- FR/IT/DE/NL	EUDAMED	Class IIa	Active
Perfect PFE for Men	K-PPFE-MEN	EUDAMED	Class IIa	Active
Unicare	K-UNICARE	EUDAMED	Class IIa	Active
Joint Electrode	E-CMSF150	EUDAMEDFDA UDI	Class I	Active
Qalm Gel Pad Refill x3 FR/NL	E-QALM-ML	EUDAMED	Class I	Active

TensCare Ltd

What TensCare Ltd makes

Frequently asked questions

Information

Catalogue (92)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)