BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NeuroMD

    DI: 04719872332503 · Model: RS-18 · ZMI ELECTRONICS LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    2

    Basic Information

    Brand Name
    NeuroMD
    Primary DI
    04719872332503
    Version / Model
    RS-18
    Catalog Number
    RS-18-MD
    Company Name
    ZMI ELECTRONICS LTD.
    Labeler DUNS
    657406062
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2023-06-15
    Public Version
    1
    Public Version Date
    2023-06-23
    Public Version Status
    New
    Public Device Record Key
    e5df9f62-a1b2-4798-9a0e-ea9b07e467f5

    Device Description

    NeuroMD RS-18 Wireless Muscle Stimulator

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Package 04719872332480
    Primary 04719872332503
    Unit of Use 04719872332497

    Premarket Submissions

    Submission Number Supplement Number
    K220997 000