510(k) clearance

S-Patch CardioAI

FDA 510(k) source

510(k) number

K254255

Applicant

Wellysis Corp.

Decision date

Sep 25, 2026

Date received

Dec 29, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DQK

Device type

Computer, Diagnostic, Programmable

Device class

Class II

Regulation

21 CFR 870.1425

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Seoul, KR