Medical Device Manufacturer · US , Cayce , SC

Rhythmlink International, LLC - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2002

Recent clearances: MR Conditional Sticky Pad Electrode, Guardian Needle Electrode, EEG Electrode Template

18

Total

18

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rhythmlink International, LLC Neurology ✕

15 devices

1-15 of 15

Cleared Feb 09, 2021

MR Conditional Sticky Pad Electrode

Neurology · 119d

Cleared May 27, 2020

Guardian Needle Electrode

Neurology · 43d

Cleared Aug 05, 2019

EEG Electrode Template

Neurology · 90d

Cleared Jul 10, 2019

PressOn Electrode Headset

Neurology · 103d

Cleared Dec 01, 2017

MR Conditional Cup Electrode, MR Conditional Webb Electrode

Neurology · 105d

Cleared Apr 11, 2014

RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE

Neurology · 274d

Cleared Jul 22, 2013

MR CONDITIONAL PRESSON ELECTRODE

Neurology · 174d

Cleared May 30, 2013

MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE

Neurology · 114d

Cleared Jul 12, 2012

PRESSON ELECTRODE

Neurology · 72d

Cleared Jun 22, 2012

EMG RECORDING ELECTRODE ASSEMBLY

Neurology · 140d

Cleared Jun 23, 2009

RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R

Neurology · 71d

Cleared Jun 23, 2009

RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R

Neurology · 71d

Cleared May 10, 2006

RHYTHMLINK DISC ELECTRODES

Neurology · 15d

Cleared Aug 23, 2005

CUTANEOUS ELECTRODE

Neurology · 12d

Cleared Dec 20, 2002

RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

Neurology · 108d