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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 K923498
Device Name BIPHASIC UNIT
Applicant
Willows Health Center
601 N. Murlen, Suite 16
Olathe,  KS  66062
Applicant Contact CRAIG SEYL
Correspondent
Willows Health Center
601 N. Murlen, Suite 16
Olathe,  KS  66062
Correspondent Contact CRAIG SEYL
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/15/1992
Decision Date 03/04/1993
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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