Cleared Traditional

ThermoPro

K161862 · Zimmer Medizinsysteme GmbH · Physical Medicine
Nov 2016
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K161862 is an FDA 510(k) clearance for the ThermoPro, a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMJ), submitted by Zimmer Medizinsysteme GmbH (Neu-Ulm, DE). The FDA issued a Cleared decision on November 14, 2016, 131 days after receiving the submission on July 6, 2016. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number K161862 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2016
Decision Date November 14, 2016
Days to Decision 131 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5290