Cleared Traditional

FORTE CB

K951746 · Chattanooga Group, Inc. · Physical Medicine

Jun 1995

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K951746 is an FDA 510(k) clearance for the FORTE CB, 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 21, 1995, 97 days after receiving the submission on March 16, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K951746 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 1995
Decision Date	June 21, 1995
Days to Decision	97 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