510(k) K011243

CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 by Chattanooga Group, Inc. — Product Code LSB

K011243 is an FDA 510(k) premarket notification submitted by Chattanooga Group, Inc. for the device "CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000". The FDA issued a decision of Substantially Equivalent on July 6, 2001. The device falls under product code LSB (Unit, Fluidotherapy), a Class II device regulated under 21 CFR 890.5100. Chattanooga Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2001
Date Received
April 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Fluidotherapy
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type