Cleared Special

S-Patch (S-Patch ExL)

K233906 · Wellysis Corp. · Cardiovascular
Feb 2024
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K233906 is an FDA 510(k) clearance for the S-Patch (S-Patch ExL), a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Wellysis Corp. (Seoul, KR). The FDA issued a Cleared decision on February 16, 2024, 66 days after receiving the submission on December 12, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K233906 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2023
Decision Date February 16, 2024
Days to Decision 66 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800