BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ReBuilder

    DI: 00866650000315 · Model: 300 · REBUILDER MEDICAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ReBuilder
    Primary DI
    00866650000315
    Version / Model
    300
    Company Name
    REBUILDER MEDICAL INC.
    Labeler DUNS
    831001404
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-28
    Public Version
    8
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    d57dd3bf-5a76-4908-ab52-9370b4a4d790

    Device Description

    Stimulator, nerve, transcutaneous, for pain relief. The ReBuilder is an intelligent medical device that relieves chronic pain by calming erratic nerve signals, strengthening muscles, and restoring local blood flow.

    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
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00866650000315

    Customer Contacts

    Phone
    304-725-2202
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K882980 000