Data / Medical devices / South Korea / Nuga Medical Co Ltd
Nuga Medical Co Ltd: FDA-registered device maker in Wonju Gangwon, South Korea, 2 510(k) clearances
Nuga Medical Co Ltd is registered with the FDA (registration 3004006265) in Wonju Gangwon, South Korea. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004006265
- Address
- 185, Jiraeul-ro, Jijeong-myeon, Wonju Gangwon, South Korea, 26355
- Owner or operator
- NUGA MEDICAL CO., LTD (9055867)
- Roles
- Manufacturer
- First device listed
- April 8, 2008
- Registered through
- 2026
- Brand names listed
- E3, E5, N4, N5, N5-1, N7-S, NM-2500H, NM-2500I and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| Table, Physical Therapy, Multi Function | JFB | 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 |
|---|---|---|---|---|---|---|
| September 12, 2024 | K240168 | N7-S | JFB | Substantially Equivalent | Nuga Medical Co., Ltd. | accessdata.fda.gov |
| February 5, 2016 | K153054 | N5-1 | JFB | Substantially Equivalent | Nuga Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Massager, Therapeutic, Electric
- All makers of Table, Physical Therapy, Multi Function
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Pad, Heating, Powered
- All makers of Massager, Powered Inflatable Tube
Updated September 12, 2024. 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.