BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Flexi TENS

    DI: 05060079210217 · Model: TN-FLEXITENS · BODY CLOCK HEALTH CARE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Flexi TENS
    Primary DI
    05060079210217
    Version / Model
    TN-FLEXITENS
    Company Name
    BODY CLOCK HEALTH CARE LIMITED
    Labeler DUNS
    504712829
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-12
    Public Version
    4
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    a99dc5c7-8b6d-479c-ad45-2f4c0a3e752c

    Device Description

    The Flexi TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Primary 05060079210217

    Premarket Submissions

    Submission Number Supplement Number
    K041164 000