Cleared Traditional

FORTE, MODELS CPS 400 STIM, CPS 200 STIM

K982828 · Chattanooga Group, Inc. · Physical Medicine
Nov 1998
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K982828 is an FDA 510(k) clearance for the FORTE, MODELS CPS 400 STIM, CPS 200 STIM, 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 November 6, 1998, 87 days after receiving the submission on August 11, 1998. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K982828 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1998
Decision Date November 06, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850