Daesung Maref Co., Ltd.

FDA Regulatory Profile

Daesung Maref Co., Ltd. has 0 FDA recalls, 2 inspections, 14 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 26, 2018 · NAI
Latest 510(k)
Jul 19, 2023

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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) clearances14Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 26, 2018Gunpo, Korea (The Republic Of)DevicesNo Action Indicated (NAI)3004116008
Jun 4, 2015Gunpo, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3004116008

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
K231437LF900Jul 19, 2023
K202395SP-1000, SP-2000Sep 1, 2021
K203498LX9maxJul 2, 2021
K203019LF900Jun 22, 2021
K203353DVT-PROApr 22, 2021
K203417DVT-4000SMar 28, 2021
K203016DVT-2600Dec 5, 2020
K160178Lympha-Flow(LF1200)Jan 11, 2017
K160180Intermittent Pneumatic Compression systemNov 3, 2016
K150980Venous Assist SystemMay 12, 2016
K150033Air Compressible Limb Therapy SystemApr 20, 2015
K112441COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEMJan 17, 2012
K112677THE VENOUS ASSIST SYSTEMJan 13, 2012
K102320COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)Mar 4, 2011