Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003446042

FEI Number

3003446042

Entity Name

TENSCARE LTD.

City/State/Country

EPSOM Surrey, GB

Establishment Address

PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK, EPSOM Surrey KT19 9BE, GB

Establishment Type(s)

Foreign Private Label Distributor,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TENSCARE LTD. (Owner Number: 9046089)

Owner / Operator Contact Address

PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK, EPSOM, GB-SRY KT19 9BE, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140168

PMA Number

N/A

All Registered Proprietary Names

Unicare Sports TENS 2 Perfect EMS Form Unifit Form Duo Nouri Duo EmbaGyn itouch Sure GoGel TensCare itouch Easy Tenscare itouch Plus Carbon Mesh Electrode pads 50X50 mm Hypoallergenic Electrode pads 50X50 mm Cooling Electrode pads 50X50 mm Cooling Electrode pads 50X100 mm Carbon Mesh Electrode pads 50X100 mm Face Electrode pads Butterfly Electrode pads Circle Electrode pads 25mm dia Neck Electrode Carbon Mesh Electrode pads 50X50 mm Joint Electrode pads Ova+ Electrode pads 90x50mm Knee Electrode Carbon Mesh Electrode pads 50x100mm Back Electrode Ova3 Ova+ Nouri Auto Pain Aide Perfect TENS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2023-10-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-11-12
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-11-12
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-11-03
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2011-09-22
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2020-08-24
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2010-12-02
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-11-04
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-11-03
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-01-15
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-11-03
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-09-22

Official Correspondent

Raluca Constantinescu

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

TENSCARE LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003446042. Last updated year: 2026. Please use registration number 3003446042 when referencing this establishment in official correspondence.