Cleared Traditional

eMVFit (MVF-10M)

K240992 · Weero Co., Ltd. · Physical Medicine
Oct 2024
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K240992 is an FDA 510(k) clearance for the eMVFit (MVF-10M), a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Weero Co., Ltd. (Suwon, KR). The FDA issued a Cleared decision on October 10, 2024, 182 days after receiving the submission on April 11, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K240992 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2024
Decision Date October 10, 2024
Days to Decision 182 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850