Cleared Traditional

FORTE

K953614 · Chattanooga Group, Inc. · Physical Medicine

Oct 1995

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K953614 is an FDA 510(k) clearance for the FORTE, 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 October 27, 1995, 85 days after receiving the submission on August 3, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K953614 FDA.gov
FDA Decision	Cleared SN
Date Received	August 03, 1995
Decision Date	October 27, 1995
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—

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