# Wellysis Corp.

- Location (FDA's records): Seoul, KR
- FDA decisions: 3 (2023–2026): 3 510(k) clearances
- Product codes: DSH (2), DPS (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Braemar Manufacturing, LLC: 1 (https://510kreport.com/company/braemar-manufacturing)
- Medicalgorithmics S.A.: 1 (https://510kreport.com/company/medicalgorithmics)

## Firms that cite its devices most
- Smwmed, Inc.: 1 (https://510kreport.com/company/smwmed)
- Seers Technology Co., Ltd.: 1 (https://510kreport.com/company/seers-technology)

## Its most-cited devices
- K231289: S-Patch Ex Wearable ECG Patch (2023), cited by 3

## Recent decisions
- K254255: S-Patch CardioAI (Sep 25, 2026)
- K233906: S-Patch  (S-Patch ExL) (Feb 16, 2024)
- K231289: S-Patch Ex Wearable ECG Patch (Aug 30, 2023)

Source page: https://510kreport.com/company/wellysis