510(k) K233906

S-Patch (S-Patch ExL) by Wellysis Corp. — Product Code DSH

K233906 is an FDA 510(k) premarket notification submitted by Wellysis Corp. for the device "S-Patch (S-Patch ExL)". The FDA issued a decision of Substantially Equivalent on February 16, 2024. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Wellysis Corp. has at least 1 other 510(k) clearance on record.