Cleared Traditional

SONICATOR PLUS

K921436 · Mettler Electronics Corp. · Physical Medicine

Apr 1993

Decision

398d

Days

Class 2

Risk

About This 510(k) Submission

K921436 is an FDA 510(k) clearance for the SONICATOR PLUS, 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 April 27, 1993, 398 days after receiving the submission on March 25, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K921436 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 1992
Decision Date	April 27, 1993
Days to Decision	398 days
Submission Type	Traditional
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