Cleared Traditional

CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000

K011243 · Chattanooga Group, Inc. · Physical Medicine

Jul 2001

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K011243 is an FDA 510(k) clearance for the CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000, a Unit, Fluidotherapy (Class II — Special Controls, product code LSB), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on July 6, 2001, 74 days after receiving the submission on April 23, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number	K011243 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2001
Decision Date	July 06, 2001
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement