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Gtg Wellness Co., Ltd.

FDA Regulatory Profile

Gtg Wellness Co., Ltd. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Mar 23, 2023 · VAI
Latest 510(k)
Jun 22, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 23, 2023Yongin, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3012113199
Mar 23, 2023Gyeonggi-Do, Korea (The Republic Of)DevicesOfficial Action Indicated (OAI)3017141552

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
K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Jun 22, 2020

FDA data resources