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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K953615
Device Name FORTE ES-400
Applicant
Chattanooga Group, Inc.
4717 Adams Rd.
P.O. Box 4287
Hixson,  TN  37343
Applicant Contact GRAHAME R WATTS
Correspondent
Chattanooga Group, Inc.
4717 Adams Rd.
P.O. Box 4287
Hixson,  TN  37343
Correspondent Contact GRAHAME R WATTS
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received08/03/1995
Decision Date 10/27/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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