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Rhythmlink International, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K203079MR Conditional Sticky Pad ElectrodeFebruary 9, 2021
K200984Guardian Needle ElectrodeMay 27, 2020
K191225EEG Electrode TemplateAugust 5, 2019
K190801PressOn Electrode HeadsetJuly 10, 2019
K172503MR Conditional Cup Electrode, MR Conditional Webb ElectrodeDecember 1, 2017
K132138RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBEApril 11, 2014
K130220MR CONDITIONAL PRESSON ELECTRODEJuly 22, 2013
K130287MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODEMay 30, 2013
K121347PRESSON ELECTRODEJuly 12, 2012
K120342EMG RECORDING ELECTRODE ASSEMBLYJune 22, 2012
K112435RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENTSeptember 22, 2011
K103200PROPEP DELIVERY DEVICEApril 12, 2011
K091055RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252RJune 23, 2009
K091056RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252RJune 23, 2009
K072736RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENTJanuary 22, 2008
K061148RHYTHMLINK DISC ELECTRODESMay 10, 2006
K052188CUTANEOUS ELECTRODEAugust 23, 2005
K022914RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODESDecember 20, 2002