Cleared Traditional

FORTE ES-400

K953615 · Chattanooga Group, Inc. · Physical Medicine
Oct 1995
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K953615 is an FDA 510(k) clearance for the FORTE ES-400, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), 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 890.5850.

Submission Details

510(k) Number K953615 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 IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850