Cleared Traditional

TrainFES Advance

K241488 · Trainfes · Physical Medicine
Feb 2025
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K241488 is an FDA 510(k) clearance for the TrainFES Advance, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Trainfes (Las Condes, CL). The FDA issued a Cleared decision on February 5, 2025, 257 days after receiving the submission on May 24, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K241488 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2024
Decision Date February 05, 2025
Days to Decision 257 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