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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 K904509
Device Name POWER TRAINER WITH NEUROMUSCULAR STIMULATION
Applicant
Sinties Scientific, Inc.
1216 N. Lansing Ave.
Tulsa,  OK  74106
Applicant Contact LAWRENCE BORN
Correspondent
Sinties Scientific, Inc.
1216 N. Lansing Ave.
Tulsa,  OK  74106
Correspondent Contact LAWRENCE BORN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/02/1990
Decision Date 02/12/1992
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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