Cleared Traditional

INTELECT 222 P

K930307 · Chattanooga Group, Inc. · Physical Medicine

Jul 1993

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K930307 is an FDA 510(k) clearance for the INTELECT 222 P, 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 July 2, 1993, 162 days after receiving the submission on January 21, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K930307 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 1993
Decision Date	July 02, 1993
Days to Decision	162 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