Cleared Traditional

THERAPEUTIC ULTRASOUND AND STIMULATOR

K935271 · Chattanooga Group, Inc. · Physical Medicine

Feb 1994

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K935271 is an FDA 510(k) clearance for the THERAPEUTIC ULTRASOUND AND STIMULATOR, 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 February 2, 1994, 92 days after receiving the submission on November 2, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K935271 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 1993
Decision Date	February 02, 1994
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

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