Data / Medical devices / South Korea / Wellysis Corp.
Wellysis Corp.: FDA-registered device maker in Gangnam-gu, Seoul, South Korea, 3 510(k) clearances
Wellysis Corp. is registered with the FDA (registration 3029915537) in Gangnam-gu, Seoul, South Korea. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 25, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3029915537
- Address
- 8F, 425 Teheran-ro, Gangnam-gu, Seoul, South Korea, 06159
- Owner or operator
- Wellysis Corp. (10088983)
- Roles
- Manufacturer
- First device listed
- October 26, 2023
- Registered through
- 2027
- Brand names listed
- S-Patch CardioAI, S-Patch Ex, S-Patch ExL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Manufacturer | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 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 25, 2026 | K254255 | S-Patch CardioAI | DQK | Substantially Equivalent | Wellysis Corp. | accessdata.fda.gov |
| February 16, 2024 | K233906 | S-Patch (S-Patch ExL) | MWJ | Substantially Equivalent | Wellysis Corp. | accessdata.fda.gov |
| August 30, 2023 | K231289 | S-Patch Ex Wearable ECG Patch | DSH | Substantially Equivalent | Wellysis Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Recorder, Magnetic Tape, Medical
- All makers of Electrocardiograph
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
Updated September 25, 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.