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Data / Medical devices / United States / FKA Distributing Co., LLC

FKA Distributing Co., LLC: FDA-registered device maker in Riverside, CA, United States, 22 510(k) clearances

FKA Distributing Co., LLC is registered with the FDA (registration 3016452327) in Riverside, CA, United States. It lists 13 device types. The FDA files 22 510(k) clearances under its listings, the newest dated December 22, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3016452327
Address
12215 Holly St. --, Riverside, CA, United States, 92509
Owner or operator
FKA Brands (1832894)
Roles
Repackager or relabeler
First device listed
March 8, 2004
Registered through
2026
Brand names listed
HoMedics, HoMedics Bubble Bliss Elite Footbath, Homedics, ObusForme

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 22, 2022K222949Air Compression Leg Massager (Model: LY-670D)IRPSubstantially EquivalentZhejiang Luyao Electronics Technology Co., Ltd.accessdata.fda.gov
December 8, 2022K221862YY-A02-B Overlapped Compression TherapyIRPSubstantially EquivalentHuizhou Xinyi Technology Co., Ltd.accessdata.fda.gov
September 8, 2021K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
June 12, 2020K200521Full Automatic(NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
November 27, 2019K191673Upper Arm Blood Pressure MonitorDXNSubstantially EquivalentFamidoc Technology Company Limitedaccessdata.fda.gov
September 16, 2019K190507Full Automatic (NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
May 22, 2019K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with StethoscopeDXQSubstantially EquivalentWenzhou Renhua Instruments Co., Ltd.accessdata.fda.gov
April 3, 2019K182597Infrared thermometerFLLSubstantially EquivalentShenzhen Pango Electronic Co., Ltd.accessdata.fda.gov
July 23, 2018K171888Non-contact infrared body thermometerFLLSubstantially EquivalentHetaida Technology Co., Ltd.accessdata.fda.gov
July 6, 2016K160557Full Automatic (NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
June 14, 2016K161156Full Automatic (NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
March 13, 2016K160145Full Automatic (NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
January 7, 2016K153214Full Automatic (NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
February 7, 2014K130723FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINALNGXSubstantially EquivalentFamidoc Technology Co., Ltd.accessdata.fda.gov
June 19, 2013K130564FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
June 18, 2013K130563FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 22, 2012K122482TRANSTEK WRIST BLOOD PRESSURE MONITORDXNSubstantially EquivalentZhongshan Transtek Electronics Co., Ltd.accessdata.fda.gov
January 18, 2012K112825AVITA ARM TYPE BLOOD PRESSURE MONITORDXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
March 25, 2010K093831FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RTDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
February 16, 2010K093824FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BTDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
March 31, 2005K050491H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IFDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
March 30, 2005K050249HL168JPDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated December 22, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.