Wellysis Corp. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
S-Patch CardioAI510(k)Sep 25, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 25, 2026
S-Patch (S-Patch ExL)510(k)Feb 16, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Feb 16, 2024
S-Patch Ex Wearable ECG Patch510(k)Aug 30, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 30, 2023