Cleared Traditional

g.Estim FES

K200088 · G.Tec Medical Engineering GmbH · Physical Medicine
Oct 2020
Decision
288d
Days
Class 2
Risk

About This 510(k) Submission

K200088 is an FDA 510(k) clearance for the g.Estim FES, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AT). The FDA issued a Cleared decision on October 29, 2020, 288 days after receiving the submission on January 15, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K200088 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2020
Decision Date October 29, 2020
Days to Decision 288 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