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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 the device name listed in this FDA 510(k) record. The listed applicant is Wellysis Corp.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) 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. The listed applicant is Wellysis Corp.. The 510(k) number is K231289.

When did S-Patch Ex Wearable ECG Patch receive FDA 510(k) clearance?

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

Who is the listed applicant for S-Patch Ex Wearable ECG Patch?

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 Ex Wearable ECG Patch?

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

Related Clinical Trials

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.

NCT04624646Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic StrokeACTIVE_NOT_RECRUITINGNCT06243029A Study to Assess Multidomain Endpoints of an ECG PatchCOMPLETEDNCT06699056AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable MonitorRECRUITINGNCT07699874Continuous Remote ECG Monitoring to Predict 30-day Outcome After Hospital Discharge in Patients With Heart Failure : A Pilot Study Using a New Wearable SensorACTIVE_NOT_RECRUITINGNCT07722026This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic Monitor, in Adults With Suspected Arrhythmia Who Presented With Symptoms Such as Palpitations or Dizziness, or Who Had Cryptogenic Ischemic Stroke or TransientCOMPLETEDNCT07772817Feasibility and Usability of a Chest-Strap Ambulatory ECG Monitor in Active Individuals in Comparison With a Traditional Ambulatory ECG Patch Monitor (MoMe ARC)RECRUITING

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)

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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