Cleared Traditional

Storz Medical MAGNETOLITH Muscle Stimulator

K203710 · Storz Medical AG · Physical Medicine
May 2021
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K203710 is an FDA 510(k) clearance for the Storz Medical MAGNETOLITH Muscle Stimulator, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Storz Medical AG (Tagerwilen, CH). The FDA issued a Cleared decision on May 3, 2021, 133 days after receiving the submission on December 21, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K203710 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2020
Decision Date May 03, 2021
Days to Decision 133 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