Cleared Traditional

FORTE US

K940180 · Chattanooga Group, Inc. · Physical Medicine

Apr 1994

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K940180 is an FDA 510(k) clearance for the FORTE US, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on April 15, 1994, 93 days after receiving the submission on January 12, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K940180 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 1994
Decision Date	April 15, 1994
Days to Decision	93 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