Rhythmlink International, LLC
Columbia, SC, US
RHYTHMLINK INTERNATIONAL, LLC appears in FDA device records in Columbia, SC. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Rhythmlink International, LLC between 2002 and 2021. The busiest year on record is 2009, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203079 | MR Conditional Sticky Pad Electrode | GXY | Substantially Equivalent | |
| K200984 | Guardian Needle Electrode | GXZ | Substantially Equivalent | |
| K191225 | EEG Electrode Template | GXY | Substantially Equivalent | |
| K190801 | PressOn Electrode Headset | GXZ | Substantially Equivalent | |
| K172503 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | GXY | Substantially Equivalent | |
| K132138 | RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE | PDQ | Substantially Equivalent | |
| K130220 | MR CONDITIONAL PRESSON ELECTRODE | GXZ | Substantially Equivalent | |
| K130287 | MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE | GXY | Substantially Equivalent | |
| K121347 | PRESSON ELECTRODE | GXZ | Substantially Equivalent | |
| K120342 | EMG RECORDING ELECTRODE ASSEMBLY | IKT | Substantially Equivalent | |
| K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | ETN | Substantially Equivalent | |
| K103200 | PROPEP DELIVERY DEVICE | FMF | Substantially Equivalent | |
| K091056 | RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R | IKT | Substantially Equivalent | |
| K091055 | RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R | IKT | Substantially Equivalent | |
| K072736 | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT | ETN | Substantially Equivalent | |
| K061148 | RHYTHMLINK DISC ELECTRODES | GXY | Substantially Equivalent | |
| K052188 | CUTANEOUS ELECTRODE | GXY | Substantially Equivalent | |
| K022914 | RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES | GXZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1067162 | 3003831320 | RHYTHMLINK INTERNATIONAL, LLC | 1140 FIRST ST. SOUTH, Columbia, SC 29209 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain