510(k) K982830

FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO by Chattanooga Group, Inc. — Product Code IMG

K982830 is an FDA 510(k) premarket notification submitted by Chattanooga Group, Inc. for the device "FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Chattanooga Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1998
Date Received
August 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type