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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 K891458
Device Name SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH
Applicant
Back IN Action, Inc.
P.O. Box 789
Mountain View,  CA  94042
Applicant Contact JOSEPH L HABBART
Correspondent
Back IN Action, Inc.
P.O. Box 789
Mountain View,  CA  94042
Correspondent Contact JOSEPH L HABBART
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/15/1989
Decision Date 10/20/1989
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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