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FDA 510(k)

S-Patch (S-Patch ExL)

K-Number: K233906 · 2024-02-16

ApplicantWellysis Corp.
Decision Date2024-02-16
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S-Patch (S-Patch ExL) is the device name listed in this FDA 510(k) record. The listed applicant is Wellysis Corp.. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K233906. 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 (S-Patch ExL)?

S-Patch (S-Patch ExL) is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Wellysis Corp.. The 510(k) number is K233906.

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

S-Patch (S-Patch ExL) received FDA 510(k) clearance on 2024-02-16, under 510(k) number K233906.

Who is the listed applicant for S-Patch (S-Patch ExL)?

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 (S-Patch ExL)?

The FDA product code for S-Patch (S-Patch ExL) is DSH.

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.

K231289S-Patch Ex Wearable ECG Patch

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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