Cleared Traditional

emField

K203488 · Zimmer Medizinsysteme GmbH · Physical Medicine
Feb 2021
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K203488 is an FDA 510(k) clearance for the emField, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Zimmer Medizinsysteme GmbH (Neu-Elm, DE). The FDA issued a Cleared decision on February 19, 2021, 84 days after receiving the submission on November 27, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K203488 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2020
Decision Date February 19, 2021
Days to Decision 84 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