Cleared Abbreviated

SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM

K121059 · Zimmer Medizinsystems GmbH · Physical Medicine

Aug 2012

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K121059 is an FDA 510(k) clearance for the SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Zimmer Medizinsystems GmbH (Neu-Elm, DE). The FDA issued a Cleared decision on August 7, 2012, 123 days after receiving the submission on April 6, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K121059 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2012
Decision Date	August 07, 2012
Days to Decision	123 days
Submission Type	Abbreviated
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5860