510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Daesung Maref Co.,Ltd

Gunpo-si Gyeonggi, KR

DAESUNG MAREF CO.,LTD appears in FDA device records in Gunpo-si Gyeonggi, KR. FDA records list 14 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 14 510(k) clearances for Daesung Maref Co.,Ltd between 2011 and 2023. The busiest year on record is 2021, with 5. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Daesung Maref Co.,Ltd, by decision year
YearClearances
20111
20122
20151
20162
20171
20201
20215
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231437LF900IRPSubstantially Equivalent
K202395SP-1000, SP-2000IRPSubstantially Equivalent
K203498LX9maxIRPSubstantially Equivalent
K203019LF900IRPSubstantially Equivalent
K203353DVT-PROJOWSubstantially Equivalent
K203417DVT-4000SJOWSubstantially Equivalent
K203016DVT-2600JOWSubstantially Equivalent
K160178Lympha-Flow(LF1200)IRPSubstantially Equivalent
K160180Intermittent Pneumatic Compression systemJOWSubstantially Equivalent
K150980Venous Assist SystemJOWSubstantially Equivalent
K150033Air Compressible Limb Therapy SystemIRPSubstantially Equivalent
K112441COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEMIRPSubstantially Equivalent
K112677THE VENOUS ASSIST SYSTEMJOWSubstantially Equivalent
K102320COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)IRPSubstantially Equivalent

Registered establishments

FDA registered establishments for Daesung Maref Co.,Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30335111043033511104DAESUNG MAREF CO.,LTD32-33, LS-ro 91beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do,Republic of Korea, Anyang-si Gyeonggi 14119 KR2026
30041160083004116008DAESUNG MAREF CO.,LTD298-24, Gongdan-Ro, Gunpo-si, Gyeonggi-do, 15809, KOREA, Gunpo-si Gyeonggi 15809 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain