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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K892669
Device Name COMFORTRAC, CT90 & CT100 BI-PHASICS
Applicant
Comfortrac Systems
2944 I-70 Business Loop #208
Grand Junction,  CO  81504
Correspondent
Comfortrac Systems
2944 I-70 Business Loop #208
Grand Junction,  CO  81504
Regulation Number890.5660
Classification Product Code
ISA  
Date Received04/13/1989
Decision Date 05/26/1989
Decision Substantially Equivalent (SESE)
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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