Data / Medical devices / United States / Rhythmlink International, LLC
Rhythmlink International, LLC: FDA-registered device maker in Columbia, SC, United States, 24 510(k) clearances
Rhythmlink International, LLC is registered with the FDA (registration 1067162) in Columbia, SC, United States. It lists 9 device types. The FDA files 24 510(k) clearances under its listings, the newest dated February 9, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1067162
- FEI number
- 3003831320
- Address
- 1140 First ST. South, Columbia, SC, United States, 29209
- Owner or operator
- RHYTHMLINK INTERNATIONAL, LLC (9052354)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 21, 2005
- Registered through
- 2026
- Brand names listed
- BrainHealth Headset, Detachable Disposable Monopolar Needle Electrode, Disposable Alligator Clips, Disposable Concentric Needle, Disposable Hypodermic Monopolar Needle, Disposable Monopolar Needle Electrode, Disposable Rhythmlink Template, EMG Recording Ring Electrode and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Nerve Conduction Velocity Measurement | JXE | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Needle | GXZ | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Needle, Diagnostic Electromyograph | IKT | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Neurological Tray | OJG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 9, 2021 | K203079 | MR Conditional Sticky Pad Electrode | GXY | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| May 27, 2020 | K200984 | Guardian Needle Electrode | GXZ | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| August 5, 2019 | K191225 | EEG Electrode Template | GXY | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| July 10, 2019 | K190801 | PressOn Electrode Headset | GXZ | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| December 1, 2017 | K172503 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | GXY | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| July 22, 2013 | K130220 | MR CONDITIONAL PRESSON ELECTRODE | GXZ | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| May 30, 2013 | K130287 | MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE | GXY | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| July 12, 2012 | K121347 | PRESSON ELECTRODE | GXZ | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| June 22, 2012 | K120342 | EMG RECORDING ELECTRODE ASSEMBLY | IKT | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| September 22, 2011 | K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | ETN | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| April 12, 2011 | K103200 | PROPEP DELIVERY DEVICE | FMF | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| January 22, 2008 | K072736 | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT | ETN | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| May 10, 2006 | K061148 | RHYTHMLINK DISC ELECTRODES | GXY | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| August 23, 2005 | K052188 | CUTANEOUS ELECTRODE | GXY | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| March 18, 2003 | K023472 | LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 | GXZ | Substantially Equivalent | Class A Enterprises, Inc. | accessdata.fda.gov |
| December 20, 2002 | K022914 | RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES | GXZ | Substantially Equivalent | Rhythmlink International, LLC | accessdata.fda.gov |
| June 22, 1999 | K982950 | FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 | IKT | Substantially Equivalent | Chalgren Enterprises, Inc. | accessdata.fda.gov |
| January 29, 1996 | K955335 | DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE | IKT | Substantially Equivalent | Chalgren Enterprises, Inc. | accessdata.fda.gov |
| January 22, 1996 | K953356 | EMG RECORDING RING ELECTRODE | GXY | Substantially Equivalent | Chalgren Enterprises, Inc. | accessdata.fda.gov |
| August 25, 1994 | K931029 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE | IKT | Substantially Equivalent | Chalgren Enterprises, Inc. | accessdata.fda.gov |
| October 5, 1992 | K923665 | REUSABLE DUAL DISC BAR RECORDING ELECTRODES | JXE | Substantially Equivalent | Chalgren Enterprises, Inc. | accessdata.fda.gov |
| September 11, 1992 | K921504 | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS | JXE | Substantially Equivalent | Chalgren Enterprises, Inc. | accessdata.fda.gov |
| March 16, 1992 | K912283 | DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | IKT | Substantially Equivalent | Chalgren Enterprises, Inc. | accessdata.fda.gov |
| March 16, 1992 | K912282 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS | IKT | Substantially Equivalent | Chalgren Enterprises, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Electrode, Needle
- All makers of Cable, Electrode
- All makers of Stimulator, Nerve
- All makers of Electrode, Needle, Diagnostic Electromyograph
- All makers of Device, Nerve Conduction Velocity Measurement
Updated February 9, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.