BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bio Protech

    DI: 00817120020562 · Model: MaxTens 1k Unit · BIO PROTECH USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bio Protech
    Primary DI
    00817120020562
    Version / Model
    MaxTens 1k Unit
    Company Name
    BIO PROTECH USA, INC.
    Labeler DUNS
    789127011
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    8
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    218fcf23-5819-4eaa-a542-f6dad5a02806

    Device Description

    MaxTens 1k - Analog Tens Unit, with Black Carrying Case

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Package 20817120020566
    Package 10817120020569
    Primary 00817120020562

    Customer Contacts

    Phone
    714-730-9950
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K073438 000