Cleared Traditional

FORTE US

K941561 · Chattanooga Group, Inc. · Physical Medicine

Jun 1994

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K941561 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 June 20, 1994, 80 days after receiving the submission on April 1, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K941561 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 1994
Decision Date	June 20, 1994
Days to Decision	80 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