Data / Medical devices / South Korea / Edgecare Inc.
Edgecare Inc.: FDA-registered device maker in Yeongdeungpo-gu Seoul, South Korea, 3 510(k) clearances
Edgecare Inc. is registered with the FDA (registration 3031569584) in Yeongdeungpo-gu Seoul, South Korea. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3031569584
- Address
- 12F, 8 Yangpyeong-ro 25-gil, Yeongdeungpo-gu Seoul, South Korea, 07207
- Owner or operator
- Edgecare Inc. (10090903)
- Roles
- Manufacturer
- First device listed
- May 30, 2024
- Registered through
- 2026
- Brand names listed
- EdgeFlow Gel Pad, EdgeFlow UH10, EdgeFlow UH10L, EdgeFlow UH10S, EdgeFlow UW20
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Media, Coupling, Ultrasound | MUI | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
|---|---|---|---|---|---|---|
| April 24, 2026 | K252337 | EdgeFlow Gel Pad | MUI | Substantially Equivalent | Edgecare, Inc. | accessdata.fda.gov |
| April 17, 2026 | K252237 | EdgeFlow UW20 | IYO | Substantially Equivalent | Edgecare, Inc. | accessdata.fda.gov |
| March 6, 2024 | K231677 | EdgeFlow UH10 | IYO | Substantially Equivalent | Edgecare, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Coupling, Ultrasound
- All makers of Automated Radiological Image Processing Software
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated April 24, 2026. 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.