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.
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- 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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Specification developer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Specification developer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2021 | K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 12, 2020 | K200521 | Full Automatic(NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| September 16, 2019 | K190507 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 13, 2019 | K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UB | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| May 20, 2019 | K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 17, 2018 | K180240 | Full Automatic(NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| September 21, 2016 | K162338 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| July 6, 2016 | K160557 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 14, 2016 | K161156 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 29, 2016 | K160336 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 13, 2016 | K160145 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| January 7, 2016 | K153214 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| August 18, 2015 | K150311 | Full Automatic (NIBP)Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| December 19, 2014 | K142968 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 19, 2013 | K130564 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 18, 2013 | K130563 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| May 29, 2013 | K131121 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 16, 2012 | K113239 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 1, 2012 | K113238 | FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| September 30, 2011 | K112320 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 25, 2010 | K093831 | FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| February 16, 2010 | K093824 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| January 22, 2010 | K093823 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| November 16, 2009 | K092163 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| September 30, 2009 | K092161 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| September 17, 2008 | K081738 | ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 | CAF | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| April 21, 2006 | K060835 | HL888SF | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| April 12, 2006 | K060729 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| April 7, 2005 | K050714 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| April 7, 2005 | K050711 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 31, 2005 | K050491 | H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 30, 2005 | K050249 | HL168JP | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| January 12, 2005 | K043437 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| December 6, 2004 | K043186 | H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| November 10, 2004 | K042853 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 26, 2004 | K042802 | H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| August 31, 2004 | K042265 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 10, 2003 | K033043 | MODIFICATION TO HL168 | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 10, 2003 | K032839 | HL888BA | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 2, 2003 | K032913 | HL888 AF | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 2, 2003 | K032695 | HL888BF | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| July 1, 2003 | K031835 | HL888RA | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| July 1, 2003 | K031695 | HL168R | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| April 24, 2003 | K030541 | HL888JF | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| April 17, 2003 | K030499 | HL888HM | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| April 11, 2003 | K030498 | HL888HA | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| January 14, 2003 | K023834 | HL888 | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| April 5, 2002 | K020766 | HL168F | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| January 16, 2002 | K014122 | HL168E | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 23, 2001 | K013033 | MODIFICATION TO: HL168W TOUCH SCREEN | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| August 22, 2001 | K012310 | MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 13, 2000 | K002882 | HL168B | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| September 18, 2000 | K002750 | HL168T | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| December 3, 1999 | K990807 | HL148 & HL168 | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
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.