Data / Medical devices / South Korea / Daesung Maref Co.,ltd
Daesung Maref Co.,ltd: FDA-registered device maker in Gunpo-si Gyeonggi, South Korea, 7 510(k) clearances
Daesung Maref Co.,ltd is registered with the FDA (registration 3004116008) in Gunpo-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 19, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004116008
- Address
- 298-24, Gongdan-Ro, Gunpo-si, Gyeonggi-do, 15809, KOREA, Gunpo-si Gyeonggi, South Korea, 15809
- Owner or operator
- DAESUNG MAREF CO.,LTD (10023845)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 22, 2015
- Registered through
- 2026
- Brand names listed
- ARM SLEEVE (M402, L402, 4AAGF3A), ARM Sleeve (4AAGF3A), ASSIST BAND (CTCAS00), Arm sleeve, BLUE MAIN HOSE (1000190), CALF SLEEVE, CENTER BODY Sleeve (4SAGF5A), CONE DOUBLE CUFF (DTC-CD25, DTC-CD26, DTC-CD27) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Powered | BXB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 19, 2023 | K231437 | LF900 | IRP | Substantially Equivalent | Daesung Maref Co., Ltd. | accessdata.fda.gov |
| September 1, 2021 | K202395 | SP-1000, SP-2000 | IRP | Substantially Equivalent | Daesung Maref Co., Ltd. | accessdata.fda.gov |
| July 2, 2021 | K203498 | LX9max | IRP | Substantially Equivalent | Daesung Maref Co., Ltd. | accessdata.fda.gov |
| April 22, 2021 | K203353 | DVT-PRO | JOW | Substantially Equivalent | Daesung Maref Co., Ltd. | accessdata.fda.gov |
| March 28, 2021 | K203417 | DVT-4000S | JOW | Substantially Equivalent | Daesung Maref Co., Ltd. | accessdata.fda.gov |
| December 5, 2020 | K203016 | DVT-2600 | JOW | Substantially Equivalent | Daesung Maref Co., Ltd. | accessdata.fda.gov |
| April 20, 2015 | K150033 | Air Compressible Limb Therapy System | IRP | Substantially Equivalent | Daesung Maref Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Sleeve, Limb, Compressible
- All makers of Massager, Powered Inflatable Tube
- All makers of Exerciser, Powered
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Tourniquet, Pneumatic
Updated July 19, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.