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Wonjin Mulsan Co., Ltd.

FDA Regulatory Profile

Wonjin Mulsan Co., Ltd. has 0 FDA recalls, 2 inspections, 5 510(k) clearances and 1 compliance action on record.

Latest inspection
Oct 22, 2015 · OAI
Latest 510(k)
Sep 14, 2021

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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) clearances5Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 22, 2015Seo, Korea (The Republic Of)DevicesOfficial Action Indicated (OAI)3006797972
Apr 4, 2013Seo, Korea (The Republic Of)DevicesOfficial Action Indicated (OAI)3006797972

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
K211283Compressible Limb and Circulation Therapy System, Model POWER-Q2300Sep 14, 2021
K200660Compressible Limb and Circulation Therapy SystemMar 8, 2021
K113275COMPRESSIBLE LIMB THERAPY SYSTEMFeb 27, 2012
K100656COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)May 26, 2010
K080134COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)Jan 23, 2009

FDA data resources