Cleared Traditional

FORTE, MODEL CPS ULTRASOUND

K982829 · Chattanooga Group, Inc. · Physical Medicine

Nov 1998

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K982829 is an FDA 510(k) clearance for the FORTE, MODEL CPS ULTRASOUND, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), 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 890.5300.

Submission Details

510(k) Number	K982829 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	IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5300