FDA.reportPublic FDA data

FKA Distributing Co., LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18328941832894FKA Distributing Co., LLC1Y2026-01-013000 N Pontiac Trl Commerce Township MI US 48390
30164523273016452327FKA Distributing Co., LLC1Y2026-01-0112215 Holly St. -- Riverside CA US 92509

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
334882056201080K222949Air Compression Leg Massager (Model: LY-670D)IRP2022-12-22
2368752056201080K222949Air Compression Leg Massager (Model: LY-670D)IRP2022-12-22
334881896093516K221862YY-A02-B Overlapped Compression TherapyIRP2022-12-08
2368751896093516K221862YY-A02-B Overlapped Compression TherapyIRP2022-12-08
2368751412857781K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMDXN2021-09-08
334881412857781K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMDXN2021-09-08
2368751145828635K200521Full Automatic(NIBP) Blood Pressure MonitorDXN2020-06-12
334881145828635K200521Full Automatic(NIBP) Blood Pressure MonitorDXN2020-06-12
334881585280188K191673Upper Arm Blood Pressure MonitorDXN2019-11-27
2368751585280188K191673Upper Arm Blood Pressure MonitorDXN2019-11-27
2368751606989286K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with StethoscopeDXQ2019-05-22
334881606989286K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with StethoscopeDXQ2019-05-22
334881815649670K190869Pulse OximeterDQA2019-09-13
334881823760313K190507Full Automatic (NIBP) Blood Pressure MonitorDXN2019-09-16
2368751823760313K190507Full Automatic (NIBP) Blood Pressure MonitorDXN2019-09-16
334881221324432K183602SwimCount Sperm Quality TestPOV2019-06-27
334881611848352K182597Infrared thermometerFLL2019-04-03
2368751611848352K182597Infrared thermometerFLL2019-04-03
334881679514872K171888Non-contact infrared body thermometerFLL2018-07-23
2368751679514872K171888Non-contact infrared body thermometerFLL2018-07-23
334881313750389K162106Micro-current Wrinkle Reduction Facial service, model EP-400NFO2017-02-03
334881607565681K162098LED Phototherapy DeviceOLP2017-01-30
334881925872612K161156Full Automatic (NIBP) Blood Pressure MonitorDXN2016-06-14
2368751925872612K161156Full Automatic (NIBP) Blood Pressure MonitorDXN2016-06-14
334881453039236K160557Full Automatic (NIBP) Blood Pressure MonitorDXN2016-07-06
2368751453039236K160557Full Automatic (NIBP) Blood Pressure MonitorDXN2016-07-06
334881875070529K160145Full Automatic (NIBP) Blood Pressure MonitorDXN2016-03-13
2368751875070529K160145Full Automatic (NIBP) Blood Pressure MonitorDXN2016-03-13
334881409821228K153214Full Automatic (NIBP) Blood Pressure MonitorDXN2016-01-07
2368751409821228K153214Full Automatic (NIBP) Blood Pressure MonitorDXN2016-01-07
334882052434901K141105PULSE OXIMETERDQA2014-12-04
2368751994020454K130723FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINALNGX2014-02-07
334881994020454K130723FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINALNGX2014-02-07
2368751962734366K130564FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORDXN2013-06-19
334881962734366K130564FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORDXN2013-06-19
334881446653562K130563FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORDXN2013-06-18
2368751446653562K130563FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORDXN2013-06-18
334881466972894K122482TRANSTEK WRIST BLOOD PRESSURE MONITORDXN2012-10-22
2368751466972894K122482TRANSTEK WRIST BLOOD PRESSURE MONITORDXN2012-10-22
334882036399105K120058TRANSTEK BLOOD PRESSURE MONITORDXN2012-01-31
334881184751474K113239FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)DXN2012-03-16
334881332482350K112825AVITA ARM TYPE BLOOD PRESSURE MONITORDXN2012-01-18
2368751332482350K112825AVITA ARM TYPE BLOOD PRESSURE MONITORDXN2012-01-18
2368751111900112K093831FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RTDXN2010-03-25
334881111900112K093831FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RTDXN2010-03-25
334881298606507K093824FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BTDXN2010-02-16
2368751298606507K093824FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BTDXN2010-02-16
334881306973463K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQA2008-11-10
334881911845046K081160AVITA RADAR THERMO IR THERMOMETER, NT1 SERIESFLL2008-06-24
334881597508389K050491H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IFDXN2005-03-31
2368751597508389K050491H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IFDXN2005-03-31
334882067186488K050249HL168JPDXN2005-03-30
2368752067186488K050249HL168JPDXN2005-03-30
334881811531689
334881031502819
2368751031502819
334881057854851
334881118671076
2368751118671076
2368751209766834
334881209766834
334881225992922
2368751225992922
334881381787124
334881434803585
2368751434803585
334881837837989
334881944888963
2368751944888963

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN342021-09-08
FLL52019-04-03
IRP42022-12-22
DQA32019-09-13
DXQ22019-05-22
NGX22014-02-07
POV12019-06-27
NFO12017-02-03
OLP12017-01-30

GUDID#

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