510(k) K083433

INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 by Chattanooga Group — Product Code IMJ

K083433 is an FDA 510(k) premarket notification submitted by Chattanooga Group for the device "INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601". The FDA issued a decision of Substantially Equivalent on March 18, 2009. The device falls under product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Chattanooga Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2009
Date Received
November 20, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type