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Health & Life Co., Ltd.

FDA Regulatory Profile

Health & Life Co., Ltd. has 0 FDA recalls, 2 inspections, 60 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 19, 2014 · VAI
Latest 510(k)
Nov 24, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances60Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 19, 2014New Taipei City, TaiwanDevicesVoluntary Action Indicated (VAI)3004016594
Jun 24, 2010New Taipei City, TaiwanDevicesVoluntary Action Indicated (VAI)3004016594

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K211744Non-Contact Infrared Thermometer, model HL710HNov 24, 2021
K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMSep 8, 2021
K200521Full Automatic(NIBP) Blood Pressure MonitorJun 12, 2020
K190507Full Automatic (NIBP) Blood Pressure MonitorSep 16, 2019
K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UBJun 13, 2019
K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TBMay 20, 2019
K180240Full Automatic(NIBP) Blood Pressure MonitorOct 17, 2018
K162338Full Automatic (NIBP) Blood Pressure MonitorSep 21, 2016
K160557Full Automatic (NIBP) Blood Pressure MonitorJul 6, 2016
K161156Full Automatic (NIBP) Blood Pressure MonitorJun 14, 2016
K160336Full Automatic (NIBP) Blood Pressure MonitorMar 29, 2016
K160145Full Automatic (NIBP) Blood Pressure MonitorMar 13, 2016
K153214Full Automatic (NIBP) Blood Pressure MonitorJan 7, 2016
K150311Full Automatic (NIBP)Blood Pressure MonitorAug 18, 2015
K142968Full Automatic (NIBP) Blood Pressure MonitorDec 19, 2014
K130564FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORJun 19, 2013
K130563FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORJun 18, 2013
K131121FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITORMay 29, 2013
K110074HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEMMay 25, 2012
K113239FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)Mar 16, 2012

FDA data resources