Cleared Traditional

INTELECT LEGEND ULTRASOUND

K973024 · Chattanooga Group, Inc. · Physical Medicine

Nov 1997

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K973024 is an FDA 510(k) clearance for the INTELECT LEGEND 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 10, 1997, 88 days after receiving the submission on August 14, 1997. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K973024 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 1997
Decision Date	November 10, 1997
Days to Decision	88 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