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VivaLNK, Inc.

FDA Regulatory Profile

VivaLNK, Inc. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 10, 2021 · VAI
Latest 510(k)
Jan 7, 2020

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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 actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 10, 2021Campbell, CADevicesVoluntary Action Indicated (VAI)3011651103
Jan 8, 2018Campbell, CADevicesNo Action Indicated (NAI)3011651103

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
K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchJan 7, 2020
K181013Fever ScoutAug 21, 2018
K162137Fever Scout™ Continuous Monitoring thermometerJan 19, 2017

FDA data resources