BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RHYTHMLINK INTERNATIONAL, LLC

    Reg #: 1067162 · FEI: 3003831320 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    RHYTHMLINK INTERNATIONAL, LLC
    Registration Number
    1067162
    FEI Number
    3003831320
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1140 FIRST ST. SOUTH
    City
    Columbia
    State
    SC
    ZIP
    29209
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982950

    Owner / Operator

    Firm Name
    RHYTHMLINK INTERNATIONAL, LLC
    Operator Number
    9052354
    Address
    1140 FIRST ST. SOUTH, --
    City
    Columbia
    State
    SC
    Postal Code
    29209
    Country
    US
    Correspondent
    Sandra O'Reilly

    Products

    Device Name Product Code
    Electrode, Needle, Diagnostic Electromyograph IKT
    Electrode, Cutaneous GXY
    Stimulator, Nerve ETN
    Electrode, Needle GXZ
    Device, Nerve Conduction Velocity Measurement JXE
    Syringe, Piston FMF
    Instrument, Manual, Surgical, General Use MDM
    Cable, Electrode IKD

    Proprietary Names

    Fine Wire Electrode RLI CUTANEOUS DISPOSABLE ELECTRODE RHYTHMLINK DISC ELECTRODES RLSP210 MSP RLSP210-03 MSP RHYTHMLINK INTL. SUBD Low Profile EEG Needle Electrode Detachable Disposable Monopolar Needle Electrode MR Conditional Web Electrode MR Conditional Cup Electrode Disposable Concentric Needle MR Conditional PressOn Electrode MSP Reusable Dual Disc Bar Recording Electrode PressOn Electrode for Prolonged Use Pep Introducer Needle Disposable Hypodermic Monopolar Needle Guardian Needle Electrode BrainHealth Headset Pep Electrode Disposable Rhythmlink Template MR Conditional Sticky Pad Electrode MR Conditional Quick Connect System Reusable Dual Disc Bar Electrode EMG Recording Ring Electrode Disposable Alligator Clips Reusable, Nonsterile Extension and Adaptor Cables Nonsterile, Reusable Alligator Clips Disposable Monopolar Needle Electrode

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility