BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Mobius Therapy

    DI: 00860074002207 · Model: KTR-201 · Endless Relief
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mobius Therapy
    Primary DI
    00860074002207
    Version / Model
    KTR-201
    Company Name
    Endless Relief
    Labeler DUNS
    081154948
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-30
    Public Version
    3
    Public Version Date
    2023-05-31
    Public Version Status
    Update
    Public Device Record Key
    aeaf601d-d48e-40aa-9838-ed95fcd2056c
    Distribution End Date
    2023-05-31

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Primary 00860074002207
    Package 00860074002238

    Customer Contacts

    Phone
    303-601-4009
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K170205 000