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Data / Medical devices / Taiwan / Health & Life Corporation

Health & Life Corporation: FDA-registered device maker in Zhonghe District, New Taipei City, Taiwan, 54 510(k) clearances

Health & Life Corporation is registered with the FDA (registration 9616390) in Zhonghe District, New Taipei City, Taiwan. It lists 4 device types. The FDA files 54 510(k) clearances under its listings, the newest dated September 8, 2021. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
9616390
FEI number
3004016594
Address
9F, No.186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan, 23553
Owner or operator
Health & Life Corporation (9036725)
Roles
Specification developer
First device listed
November 3, 2005
Registered through
2026
Brand names listed
EZ Breathe Atomizer, EZ-100(HL110), Full Automatic (NIBP) Blood Pressure Monitor, HL888HD, HL168D, HL168E, HL168ET, HL168F, HL168FV and more

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
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
September 16, 2019K190507Full Automatic (NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
June 13, 2019K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UBDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
May 20, 2019K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TBDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 17, 2018K180240Full Automatic(NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
September 21, 2016K162338Full Automatic (NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life 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 29, 2016K160336Full 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
August 18, 2015K150311Full Automatic (NIBP)Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
December 19, 2014K142968Full Automatic (NIBP) Blood Pressure MonitorDXNSubstantially EquivalentHealth & Life 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
May 29, 2013K131121FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
March 16, 2012K113239FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)DXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
March 1, 2012K113238FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITORDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
September 30, 2011K112320FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.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
January 22, 2010K093823FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JMDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
November 16, 2009K092163FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KBDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
September 30, 2009K092161FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BFDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
September 17, 2008K081738ULTRASONIC NEBULIZER SYSTEM, MODEL HL100CAFSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
April 21, 2006K060835HL888SFDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
April 12, 2006K060729FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FVDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
April 7, 2005K050714FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GSDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
April 7, 2005K050711FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JTDXNSubstantially 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
January 12, 2005K043437FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ETDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
December 6, 2004K043186H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EMDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
November 10, 2004K042853FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QADXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 26, 2004K042802H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168QDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
August 31, 2004K042265FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888DXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 10, 2003K033043MODIFICATION TO HL168DXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 10, 2003K032839HL888BADXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 2, 2003K032913HL888 AFDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 2, 2003K032695HL888BFDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
July 1, 2003K031835HL888RADXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
July 1, 2003K031695HL168RDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
April 24, 2003K030541HL888JFDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
April 17, 2003K030499HL888HMDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
April 11, 2003K030498HL888HADXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
January 14, 2003K023834HL888DXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
April 5, 2002K020766HL168FDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
January 16, 2002K014122HL168EDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 23, 2001K013033MODIFICATION TO: HL168W TOUCH SCREENDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
August 22, 2001K012310MODIFICATION TO:HL168D BLOOD PRESSURE MONITORDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
October 13, 2000K002882HL168BDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
September 18, 2000K002750HL168TDXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov
December 3, 1999K990807HL148 & HL168DXNSubstantially EquivalentHealth & Life Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 8, 2021. 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.