Medical Device Manufacturer · US , Cayce , SC

Rhythmlink International, LLC

18 submissions · 18 cleared · Since 2002
18
Total
18
Cleared
0
Denied

Rhythmlink International, LLC — FDA 510(k) Submissions

Rhythmlink International, LLC has submitted 18 FDA 510(k) premarket notifications since 2002, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Cutaneous, Electrode, Needle, Electrode, Needle, Diagnostic Electromyograph, Stimulator, Nerve, Neurosurgical Nerve Locator . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
MR Conditional Sticky Pad Electrode
K203079 · GXY Electrode, Cutaneous · Neurology
Feb 2021 119d
Guardian Needle Electrode
K200984 · GXZ Electrode, Needle · Neurology
May 2020 43d
EEG Electrode Template
K191225 · GXY Electrode, Cutaneous · Neurology
Aug 2019 90d
PressOn Electrode Headset
K190801 · GXZ Electrode, Needle · Neurology
Jul 2019 103d
MR Conditional Cup Electrode, MR Conditional Webb Electrode
K172503 · GXY Electrode, Cutaneous · Neurology
Dec 2017 105d
RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
K132138 · PDQ Neurosurgical Nerve Locator · Neurology
Apr 2014 274d
MR CONDITIONAL PRESSON ELECTRODE
K130220 · GXZ Electrode, Needle · Neurology
Jul 2013 174d
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
K130287 · GXY Electrode, Cutaneous · Neurology
May 2013 114d
PRESSON ELECTRODE
K121347 · GXZ Electrode, Needle · Neurology
Jul 2012 72d
EMG RECORDING ELECTRODE ASSEMBLY
K120342 · IKT Electrode, Needle,... · Neurology
Jun 2012 140d
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
K112435 · ETN Stimulator, Nerve · Ear, Nose, Throat
Sep 2011 29d
PROPEP DELIVERY DEVICE
K103200 · FMF Syringe, Piston · General Hospital
Apr 2011 162d
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
K091055 · IKT Electrode, Needle,... · Neurology
Jun 2009 71d
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
K091056 · IKT Electrode, Needle,... · Neurology
Jun 2009 71d
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
K072736 · ETN Stimulator, Nerve · Ear, Nose, Throat
Jan 2008 117d
RHYTHMLINK DISC ELECTRODES
K061148 · GXY Electrode, Cutaneous · Neurology
May 2006 15d
CUTANEOUS ELECTRODE
K052188 · GXY Electrode, Cutaneous · Neurology
Aug 2005 12d
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · GXZ Electrode, Needle · Neurology
Dec 2002 108d
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