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Shenzhen Fitfaith Technology Co.,Ltd

FDA Regulatory Profile

Shenzhen Fitfaith Technology Co.,Ltd has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jul 26, 2024 · OAI
Latest 510(k)
Sep 19, 2017

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 26, 2024Shenzen, ChinaDevicesOfficial Action Indicated (OAI)3014060206

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
K163135Finger Pulse OximeterSep 19, 2017

FDA data resources