Data / Medical devices / South Korea / HAENGLIM Co.,Ltd
HAENGLIM Co.,Ltd: FDA-registered device maker in -Yeoju-si Gyeonggi, South Korea, 2 510(k) clearances
HAENGLIM Co.,Ltd is registered with the FDA (registration 3008383238) in -Yeoju-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 21, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008383238
- Address
- 67, Eunbong-gil,Ganam-eup, -Yeoju-si Gyeonggi, South Korea, 12663
- Owner or operator
- Haeng Lim Co.,Ltd (10032376)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 6, 2010
- Registered through
- 2026
- Brand names listed
- acupuncture needles, probe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pressure Applying | KNM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | 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 |
|---|---|---|---|---|---|---|
| April 21, 2010 | K092240 | ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Haenglim Seowon Medical Co. | accessdata.fda.gov |
| February 28, 2001 | K002827 | MAC ACUPUNCTURE NEEDLE | MQX | Substantially Equivalent | Haenglim Seowon Corp. | accessdata.fda.gov |
Compare with other makers
Updated April 21, 2010. 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.