BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Libra TENS

    Reg #: 9710616 · FEI: 3003267895 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BODY CLOCK HEALTH CARE LTD
    Registration Number
    9710616
    FEI Number
    3003267895
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    108 GEORGE LANE
    City
    LONDON, ENGLAND London, City of
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K021846

    Owner / Operator

    Firm Name
    BODY CLOCK HEALTH CARE LTD
    Operator Number
    9048152
    Address
    108 GEORGE LANE, SOUTH WOODFORD
    City
    LONDON, ENGLAND
    State
    GB-NOTA
    Postal Code
    E18 1AD
    Country
    GB

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane, Littleton
    City
    Denver
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ

    Proprietary Names

    Libra TENS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device