Data / Medical devices / South Korea / Hansol Medical Co.
Hansol Medical Co.: FDA-registered device maker in PAJU-SI Gyeonggi, South Korea, 1 510(k) clearance
Hansol Medical Co. is registered with the FDA (registration 3005417950) in PAJU-SI Gyeonggi, South Korea. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 30, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005417950
- Address
- 89-12, Tongil-ro620beon-gil WOLLONG-MYEON, PAJU-SI Gyeonggi, South Korea, 10945
- Owner or operator
- Hansol Medical Co. (9034494)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 27, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pressure Applying | KNM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 30, 2009 | K090910 | HANSO ACUPUNCTURE NEEDLE | MQX | Substantially Equivalent | Hansol Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Manual
- All makers of Needle, Acupuncture, Single Use
- All makers of Device, Pressure Applying
Updated June 30, 2009. 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.