Wellysis Corp. is one of 440 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Wellysis Corp. - FDA 510(k) Cleared Devices
Recent clearances: S-Patch CardioAI, S-Patch (S-Patch ExL), S-Patch Ex Wearable ECG Patch
3
Total
3
Cleared
0
Denied
Wellysis Corp. has 3 FDA 510(k) cleared medical devices. Based in Seoul, KR.
Latest FDA clearance: Sep 2026. Active since 2023. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Wellysis Corp. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mcra, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Wellysis Corp.
3 devices