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Wello, Inc.

FDA Regulatory Profile

Wello, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 1 compliance action on record.

Latest inspection
Jun 21, 2023 · NAI
Latest 510(k)
Nov 30, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 21, 2023Addison, TXDevicesNo Action Indicated (NAI)3011214569
Oct 10, 2019Addison, TXDevicesVoluntary Action Indicated (VAI)3011214569

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
K180298welloStationXNov 30, 2018

FDA data resources