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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K040285
Device Name VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER
Applicant
Chattanooga Group
4717 Adams Rd.
Hixson,  TN  37343
Applicant Contact MICK DAVIS
Correspondent
Chattanooga Group
4717 Adams Rd.
Hixson,  TN  37343
Correspondent Contact MICK DAVIS
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZI   GZJ   IPF  
Date Received02/06/2004
Decision Date 04/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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