FDA 510(k)

S-Patch (S-Patch ExL)

K-Number: K233906 · 2024-02-16

Decision Date2024-02-16

Product CodeDSH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

S-Patch (S-Patch ExL) is a medical device manufactured by Wellysis Corp.. It received FDA 510(k) clearance on 2024-02-16 under approval 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. It is manufactured by Wellysis Corp.. The 510(k) number is K233906.

When was S-Patch (S-Patch ExL) approved by the FDA?

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

What company makes S-Patch (S-Patch ExL)?

S-Patch (S-Patch ExL) is manufactured by Wellysis Corp..

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 Devices by Wellysis Corp.

K231289S-Patch Ex Wearable ECG Patch

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

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