BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    TENSCARE LTD.

    Reg #: 3003446042 · FEI: 3003446042 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    38
    Establishment Types
    4
    Classifications
    8

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    Registration Details

    Registration Name
    TENSCARE LTD.
    Registration Number
    3003446042
    FEI Number
    3003446042
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK
    City
    EPSOM Surrey
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K231053

    Owner / Operator

    Firm Name
    TENSCARE LTD.
    Operator Number
    9046089
    Address
    PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK
    City
    EPSOM
    State
    Surrey
    Postal Code
    KT19 9BE
    Country
    GB
    Correspondent
    Raluca Constantinescu

    US Agent

    Business Name
    QA/RA CONSULTING GROUP, INC.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Rd
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Pump, Breast, Powered HGX
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI
    Lubricant, Personal NUC
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Electrode, Cutaneous GXY
    Massager, Therapeutic, Electric ISA

    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 Joint Electrode pads Ova+ Electrode pads 90x50mm Knee Electrode Carbon Mesh Electrode pads 50x100mm Back Electrode Ova3 Ova+ Nouri Auto Pain Aide Perfect TENS Shockwave Oko iglove isock KneeStim Sure+ Perfect PFE

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device