FDA.report

RHYTHMLINK INTERNATIONAL, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10671623003831320RHYTHMLINK INTERNATIONAL, LLC1Y2026-01-011140 FIRST ST. SOUTH Columbia SC US 29209

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
609701823022371K982950FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550IKT1999-06-22
609701821678844K955335DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODEIKT1996-01-29
609701750979979K953356EMG RECORDING RING ELECTRODEGXY1996-01-22
609701393344321K931029DISPOSABLE CONCENTRIC NEEDLE ELECTRODEIKT1994-08-25
609701124230486K923665REUSABLE DUAL DISC BAR RECORDING ELECTRODESJXE1992-10-05
609702014899148K921504REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELSJXE1992-09-11
609701330718311K912283DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODEIKT1992-03-16
609701514298093K912282DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELSIKT1992-03-16
609701165912830K203079MR Conditional Sticky Pad ElectrodeGXY2021-02-09
609701841226376K200984Guardian Needle ElectrodeGXZ2020-05-27
609701251217800K191225EEG Electrode TemplateGXY2019-08-05
609701425688522K190801PressOn Electrode HeadsetGXZ2019-07-10
609701933299581K172503MR Conditional Cup Electrode, MR Conditional Webb ElectrodeGXY2017-12-01
609701074990485K132138RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBEPDQ2014-04-11
609701074301979K130287MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODEGXY2013-05-30
609701326868922K130220MR CONDITIONAL PRESSON ELECTRODEGXZ2013-07-22
609701980074226K121347PRESSON ELECTRODEGXZ2012-07-12
609701163875283K120342EMG RECORDING ELECTRODE ASSEMBLYIKT2012-06-22
609701638857854K112435RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENTETN2011-09-22
609701697281547K103200PROPEP DELIVERY DEVICEFMF2011-04-12
609701186406220K103103PRESSON ELECTRODEGXZ2011-12-08
609701199454626K091056RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252RIKT2009-06-23
609701813776666K091055RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252RIKT2009-06-23
609701021774198K072736RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENTETN2008-01-22
609701693171605K061148RHYTHMLINK DISC ELECTRODESGXY2006-05-10
609701664135833K052188CUTANEOUS ELECTRODEGXY2005-08-23
609701603727042K023472LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812GXZ2003-03-18
609701827054431K022914RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODESGXZ2002-12-20
609701505791737

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IKT82012-06-22
GXY72021-02-09
GXZ72020-05-27
ETN22011-09-22
JXE21992-10-05
PDQ12014-04-11
FMF12011-04-12

PMN

GUDID

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