Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033511104

FEI Number

3033511104

Entity Name

DAESUNG MAREF CO.,LTD

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

32-33, LS-ro 91beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do,Republic of Korea, Anyang-si Gyeonggi 14119, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DAESUNG MAREF CO.,LTD (Owner Number: 10023845)

Owner / Operator Contact Address

298-24, Gongdan-ro, Gunpo-si, Gyeonggi-do, 15809, Korea, Gunpo-si, KR-41 15809, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203498

PMA Number

N/A

All Registered Proprietary Names

REUSABLE ANKLE WRAP (CTCAF00) ONE PERSON USE UNIVERSAL WRAP[M](CTCUMD0) REUSABLE SHOULDER WRAP(CTCSM00) REUSABLE UNIVERSAL WRAP(CTCUL00) ONE PERSON USE BACK WRAP[L](CTCBFD0) ONE PERSON USE ELBOW WRAP(CTCEFD0) CTC-7 ONE PERSON USE KNEE WRAP(CTCKFD0) REUSABLE ELBOW WRAP(CTCEF00) REUSABLE UNIVERSAL WRAP[L] (CTCUL00) REUSABLE UNIVERSAL WRAP[M](CTCUM00) ONE PERSON USE ANKLE WRAP(CTCAFD0) REUSABLE KNEE WRAP(CTCKF00) ONE PERSON USE SHOULDER WRAP(CTCSMD0) Tubing (CTC7210) ASSIST BAND (CTCAS00) ONE PERSON USE UNIVERSAL WRAP[L](CTCULD0) REUSABLE BACK WRAP (CTCBF00) ONE PERSON USE HIP WRAP[LEFT](CTCHFL0) ONE PERSON USE HIP WRAP[RIGHT](CTCHFR0) ONE PERSON USE UNIVERSAL WRAP[XL](CTCUXD0) DVT-PRO EXTENSION PAD TUBING MULTI-USE CALF SLEEVE FOOT SLEEVE CALF SLEEVE SOFT THIGH SLEEVE (DS211, DS212, DS213, DS214) DVT-4000S SOFT CALF SLEEVE (DS221, DS222, DS223, DS224) SOFT BOOT SLEEVE (DS241) NON-WOVEN THIGH SLEEVE (DS011, DS012, DS013, DS014) TUBING (DS300, DS301, DS302) NON-WOVEN CALF SLEEVE (DS021, DS022, DS023, DS024) SOFT FOOT SLEEVE (DS031, DS033) SILICONE BLADDER SINGLE CUFF (DTC-SA3443, DTC-SA2128, DTC-SA1228, DTC-SA4563) DTS-3000 BLUE MAIN HOSE (1000190) DOUBLE CUFF (DTC-D04, DTC-D05, DTC-D06, DTC-D07) IOP Sensor (0100090) CONE SINGLE CUFF (DTC-C25, DTC-C26, DTC-C27) RED MAIN HOSE (1000180) CONE DOUBLE CUFF (DTC-CD25, DTC-CD26, DTC-CD27) SILICONE BLADDER SINGLE CUFF (DTC-SA01, DTC-SA02, DTC-SA05, DTC-SA06, DTC-SA07, DTC-SA15) GRAY MAIN HOSE (1000200) SINGLE CUFF (DTC-S02,DTC-S04,DTC-S05,DTC-S06, DTC-S07, DTC-S08) SILICONE BLADDER CONE SINGLE CUFF (DTC-CS1843, DTC-CS2443, DTC-CS3043, DTC-CS3443, DTC-CS4443) SILICONE BLADDER SINGLE CUFF (DTC-SA1243, DTC-SA1843, DTC-SA2443, DTC-SA3043) SILICONE BLADDER CONE DOUBLE CUFF (DTC-CD1855, DTC-CD2455, DTC-CD3055, DTC-CD3455, DTC-CD4475) LF900 EXT.ZIPPER (4ELGL02, 4ELGX01, 4ELGY00, 4EAGF02) TUBING ARM SLEEVE (M402, L402, 4AAGF3A) LEG SLEEVE (4LAGL5A, 4LAGX40, 4LAGY00, S401, SW401, SXW401, M401, MW401, MXW401, L401, LW401, M403, MW403) SOFT CALF SLEEVE (DS221, DS222, DS223, DS224) SOFT THIGH SLEEVE (DS211, DS212, DS213, DS214) DVT-2600 NON-WOVEN THIGH SLEEVE (DS011, DS012, DS013, DS014) NON-WOVEN CALF SLEEVE (DS021, DS022, DS023, DS024) SOFT BOOT SLEEVE (DS241) SOFT FOOT SLEEVE (DS031, DS033) TUBING (DS300, DS301, DS302) LF-400 LEG sleeve Arm sleeve LX9max Center body sleeve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2019-03-18
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-04-22
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-03-29
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2019-04-03
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2023-08-08
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-03-29
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2015-04-22
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2021-07-04

Official Correspondent

No official correspondent registered.

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

DAESUNG MAREF CO.,LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004116008	DAESUNG MAREF CO.,LTD	Gunpo-si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033511104. Last updated year: 2026. Please use registration number 3033511104 when referencing this establishment in official correspondence.