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FDA 510(k)

S-Patch Ex Wearable ECG Patch

K-Number: K231289 · 2023-08-30

ApplicantWellysis Corp.
Decision Date2023-08-30
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S-Patch Ex Wearable ECG Patch is a medical device manufactured by Wellysis Corp.. It received FDA 510(k) clearance on 2023-08-30 under approval number K231289. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-Patch Ex Wearable ECG Patch?

S-Patch Ex Wearable ECG Patch is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Wellysis Corp.. The 510(k) number is K231289.

When was S-Patch Ex Wearable ECG Patch approved by the FDA?

S-Patch Ex Wearable ECG Patch received FDA 510(k) clearance on 2023-08-30, under approval number K231289.

What company makes S-Patch Ex Wearable ECG Patch?

S-Patch Ex Wearable ECG Patch is manufactured by Wellysis Corp..

What is the FDA product code for S-Patch Ex Wearable ECG Patch?

The FDA product code for S-Patch Ex Wearable ECG Patch is DSH.

Related Clinical Trials

NCT07612085 A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery NOT_YET_RECRUITING NCT04624646 Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke ACTIVE_NOT_RECRUITING NCT07240831 Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM) RECRUITING NCT05490459 Jewel Electrophysiology (EP) Lab Study COMPLETED NCT07504224 ASD Wearables Feasibility Study COMPLETED NCT06243029 A Study to Assess Multidomain Endpoints of an ECG Patch COMPLETED

Other Devices by Wellysis Corp.

K233906S-Patch (S-Patch ExL)

Related Devices (Code: DSH)

K162571Bioflux SoftwareBiotricity, Inc. K160704myPatch-sDms-Service, LLC K171936Peerbridge Cor(TM) SystemPeerbridge Health, Inc. K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc. K163535my Patch slDms-Service, LLC K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL

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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