Cleared Traditional

INTELECT, MODEL 245

K911733 · Chattanooga Group, Inc. · Physical Medicine

Dec 1991

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K911733 is an FDA 510(k) clearance for the INTELECT, MODEL 245, 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 December 17, 1991, 244 days after receiving the submission on April 17, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K911733 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 1991
Decision Date	December 17, 1991
Days to Decision	244 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