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Weero Co., Ltd.

FDA Regulatory Profile

Weero Co., Ltd. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 5, 2024 · VAI
Latest 510(k)
Jun 8, 2026

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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) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 5, 2024Suwon, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3016087653

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
K253542Apollo Quattro (APQ-10M)Jun 8, 2026
K253261Apollo Quattro (APQ-10M)Mar 13, 2026
K241433EVE Synergy (EVE-20M)Jun 4, 2025
K240992eMVFit (MVF-10M)Oct 10, 2024
K240991eMVFit (MVF-10M)Oct 9, 2024
K212253Apollo Duet (Model : APD-4000)Aug 25, 2022

FDA data resources