Cleared Special

SONICATOR PLUS 920

K111482 · Mettler Electronics Corp. · Physical Medicine

Aug 2011

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K111482 is an FDA 510(k) clearance for the SONICATOR PLUS 920, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on August 25, 2011, 90 days after receiving the submission on May 27, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K111482 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2011
Decision Date	August 25, 2011
Days to Decision	90 days
Submission Type	Special
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