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510(k) clearances

S-Patch CardioAI

Wellysis Corp. · Cardiovascular

K254255Substantially EquivalentTraditionalDPS
Open FDA's page for this record
Third party flag
N
City
Seoul
Advisory committee description
Cardiovascular
Address 1
8f, 425 Teheran-Ro Gangnam--Gu
Statement or summary
Summary
Product code
DPS
Applicant
Wellysis Corp.
Decision date
2026-09-25
Decision code
SESE
Country code
KR
Device name
S-Patch CardioAI
Advisory committee
CV
Contact
Young Juhn
K number
K254255
Date received
2025-12-29
Review advisory committee
CV
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrocardiograph
Medical specialty description
Cardiovascular
Regulation number
870.2340
Device class
2
Registration number
3004145393, 3030733800, 3031158, 1220908, 9710602, 3010838917, 3034603279, 3030446844, 8030978, 3003622639, 3008820594, 3013896610, 3018587883, 8030229, 3007836437, 3009183442, 3014579161, 3035371769, 3008293988, 3007413079, 1066427, 8030673, 3013500228, 3041276591, 3011359729, 3013501110, 2000004234, 3013557562, 3016852448, 3043226252, 3021131596, 3007734888, 3009831876, 3003174284, 3003832357, 3011353843, 3007770164, 1218950, 1450057, 1651104 +143 more
FEI number
1000271197, 3004145393, 3030733800, 1220908, 3034603279, 3010838917, 3030446844, 3003622639, 3008820594, 3013896610, 3004213967, 3003708031, 3018587883, 3007836437, 3009183442, 3014579161, 3035371769, 3008293988, 3007413079, 3013500228, 3041276591, 3011359729, 3013501110, 2000004234, 3013557562, 3016852448, 3043226252, 3021131596, 3007734888, 3009831876, 3003174284, 3003832357, 3011353843, 3007770164, 1218950, 3002807739, 1450057, 3005569927, 1000114111, 2182208 +143 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.