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FDA 510(k)

S-Patch CardioAI

K-Number: K254255 · 2026-09-25

ApplicantWellysis Corp.
Decision Date2026-09-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S-Patch CardioAI is the device name listed in this FDA 510(k) record. The listed applicant is Wellysis Corp.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254255. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-Patch CardioAI?

S-Patch CardioAI is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Wellysis Corp.. The 510(k) number is K254255.

When did S-Patch CardioAI receive FDA 510(k) clearance?

S-Patch CardioAI received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254255.

Who is the listed applicant for S-Patch CardioAI?

The FDA 510(k) record lists Wellysis Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-Patch CardioAI?

The FDA product code for S-Patch CardioAI is DPS.

Other records listing Wellysis Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233906S-Patch (S-Patch ExL)K231289S-Patch Ex Wearable ECG Patch

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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