E-Care Technology Corp.

FDA Regulatory Profile

E-Care Technology Corp. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 2 compliance actions on record.

Latest inspection
Apr 26, 2016 · NAI
Latest 510(k)
Oct 25, 2018

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions2Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 26, 2016Chubei City, TaiwanDevicesNo Action Indicated (NAI)3007557677
Jul 9, 2015Chubei City, TaiwanDevicesOfficial Action Indicated (OAI)3007557677

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
K170723Swaive Thermometer SWT1AOct 25, 2018
K113095E-CARE INFRARED EAR THERMOMETERMar 2, 2012
K021753E-CARE INFARED EAR THERMOMETER, MODEL LCT-200Aug 6, 2002