Data / Medical devices / South Korea / Ybrain Inc.
Ybrain Inc.: FDA-registered device maker in Daejeon, South Korea, 1 510(k) clearance
Ybrain Inc. is registered with the FDA (registration 3014389257) in Daejeon, South Korea. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 11, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014389257
- Address
- 2 floor, Room 202, 71, Jukdong-ro, Yuseong-gu, Daejeon, South Korea, 34127
- Owner or operator
- Ybrain Inc. (10091213)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 24, 2024
- Registered through
- 2027
- Brand names listed
- DOOPANG, UB ERP System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | 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 11, 2024 | K232749 | DOOPANG | PCC | Substantially Equivalent | Ybrain, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
Updated June 11, 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.